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WASHINGTON, September 2, 2021 Federal Trade Commissioner Noah Phillips said at a Hudson Institute webinar on Monday that hes concerned about the direction the competition watchdog is moving toward considering recent events.

Phillips said the left-leaning voices in Washington and the appointment of Lina Khan to chair the agency has left him wondering about the legacy of the last 40 years of competition regulation in America which have been hallmarked by the Hart-Scott-Rodino Antitrust Improvements Act of 1976. That legislation effectively gave the FTC the ability to review mergers and acquisitions before they were finalized, rather than afterward, which governed pre-legislation.

Under Biden-appointee Lina Khan, Phillips described how the FTC has done away with the process of early termination. In the past, this process made it unnecessary for every single company to provide advanced notice and advanced approval for mergers. Historically, parties have been able to come to the agencies and say, Youre not interested in this, can we just go ahead and finish our deal, and the agencies have said yes.

He said this is no longer the case, and that every single merger must provide advanced notice and approval. What were introducing is an inefficiency in the market for transactions that we have no interest in pursuing, just for the sake of it. I think thats a problem, he continued. My concern is that it is making merger enforcement less effective, less efficient, and less fair.

Phillips pointed to left-of-center and leftist voices in Congress, such as Rep. David Cicilline, D-New York, Sen. Elizabeth Warren, D-Massachusetts, and Rep. Alexandria Ocasio-Cortez, D-New York, who, at the outset of the pandemic, wanted to ban all acquisitions and mergersregardless of their merit. He described this view as falling outside of mainstream perspectives, but noteworthy nonetheless.

I dont think that is what most people believe, Phillips remarked. I dont think that is what Hart-Scott-Rodino envisions.

This webinar took place only a couple of weeks after Phillips spoke at the Technology Policy Institutes 2021 Aspen Forum, where he voiced similar concerns, stating that he feared that this new direction would make it more difficult for the FTC to hear cases that it should, and defended the commissions record against critics who said it was lax under the Trump Administration.

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FTC Forum Hears Evidence that U.S. Should Follow European Union Privacy Model - BroadbandBreakfast.com

Opdualag is a first-in-class, fixed-dose dual immunotherapy combination treatment of the PD-1 inhibitor nivolumab and novel LAG-3-blocking antibody relatlimab

In RELATIVITY-047, Opdualag more than doubled median progression-free survival compared to nivolumab monotherapy

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has approved the fixed-dose combination of Opdualag (nivolumab and relatlimab) for the first-line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumor cell PD-L1 expression < 1%.

The ECs decision is based upon an exploratory analysis of results from the Phase 2/3 RELATIVITY-047 trial in patients with tumor cell expression < 1%, which demonstrated that treatment with the fixed-dose combination of the PD-1 inhibitor nivolumab and novel LAG-3-blocking antibody relatlimab more than doubled the median progression-free survival (PFS) compared to nivolumab monotherapy an established standard of care. No new safety events were identified with the combination when compared to nivolumab monotherapy.

Opdualag is now the first approved LAG-3-blocking antibody combination for advanced melanoma in the European Union. The RELATIVITY-047 study demonstrated the important benefit of inhibiting both LAG-3 and PD-L1 with our novel immunotherapy combination, said Samit Hirawat, M.D., executive vice president, chief medical officer, Global Drug Development, Bristol Myers Squibb. This is a continuation of our work in bringing innovative medicines to adults and adolescents living with melanoma. Thank you to all of the patients, researchers and physicians who contributed to these advancements and made todays approval possible.

The EC decision allows for the use of Opdualag for the first-line treatment of adults and adolescents 12 years of age and older with advanced melanoma and tumor cell PD-L1 expression < 1% in all European Union member states*, as well as Iceland, Liechtenstein, and Norway.

RELATIVITY -047 Efficacy and Safety Results

The indication in the European Union is based upon an exploratory analysis of the RELATIVITY-047 data in patients with tumor cell PD-L1 expression < 1%:

The RELATIVITY-047 trial also met its primary endpoint of PFS in the all-comer population.

*Centralized Marketing Authorization does not include approval in Great Britain (England, Scotland, Wales).

About RELATIVITY-047

RELATIVITY-047 is a global, randomized, double-blind Phase 2/3 study evaluating the fixed-dose combination of nivolumab and relatlimab versus nivolumab alone in patients with previously untreated metastatic or unresectable melanoma. Patients were enrolled regardless of tumor cell PD-L1 expression. The trial excluded patients with active autoimmune disease, medical conditions requiring systemic treatment with moderate or high dose corticosteroids or immunosuppressive medications, uveal melanoma, and active or untreated brain or leptomeningeal metastases. The primary endpoint of the trial is progression-free survival (PFS) determined by Blinded Independent Central Review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST v1.1) in the all-comer population. The secondary endpoints are overall survival (OS) and objective response rate (ORR) in the all-comer population. A total of 714 patients were randomized 1:1 to receive a fixed-dose combination of nivolumab (480 mg) and relatlimab (160 mg) or nivolumab (480 mg) by intravenous infusion every four weeks until disease progression, unacceptable toxicity or withdrawal of consent.

About LAG-3

Lymphocyte-activation gene 3 (LAG-3) is a cell-surface molecule expressed on effector T cells and regulatory T cells (Tregs) and functions to control T-cell response, activation and growth. Preclinical studies indicate that inhibition of LAG-3 may restore effector function of exhausted T cells and potentially promote an anti-tumor response. Early research demonstrates that targeting LAG-3 in combination with other potentially complementary immune checkpoints may be a key strategy to more effectively potentiate anti-tumor immune activity.

Bristol Myers Squibb is evaluating relatlimab, its LAG-3-blocking antibody, in clinical trials in combination with other agents in a variety of tumor types.

About Melanoma

Melanoma is a form of skin cancer characterized by the uncontrolled growth of pigment-producing cells (melanocytes) located in the skin. Metastatic melanoma is the deadliest form of the disease and occurs when cancer spreads beyond the surface of the skin to other organs. The incidence of melanoma has been increasing steadily for the last 30 years. In the United States, 106,110 new diagnoses of melanoma and about 7,180 related deaths are estimated for 2021. Globally, the World Health Organization estimates that by 2035, melanoma incidence will reach 424,102, with 94,308 related deaths. Melanoma can be mostly treatable when caught in its very early stages; however, survival rates can decrease as the disease progresses.

Bristol Myers Squibb: Creating a Better Future for People with Cancer

Bristol Myers Squibb is inspired by a single vision transforming patients lives through science. The goal of the companys cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine, and through innovative digital platforms, are turning data into insights that sharpen their focus. Deep scientific expertise, cutting-edge capabilities and discovery platforms enable the company to look at cancer from every angle. Cancer can have a relentless grasp on many parts of a patients life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. Because as a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.

OPDUALAG U.S. INDICATION

Opdualag (nivolumab and relatlimab-rmbw) is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.

OPDUALAG IMPORTANT SAFETY INFORMATION

Severe and Fatal Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions (IMARs) listed herein may not include all possible severe and fatal immune-mediated adverse reactions.

IMARs which may be severe or fatal, can occur in any organ system or tissue. IMARs can occur at any time after starting treatment with a LAG-3 and PD-1/PD-L1 blocking antibodies. While IMARs usually manifest during treatment, they can also occur after discontinuation of Opdualag. Early identification and management of IMARs are essential to ensure safe use. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying IMARs. Evaluate clinical chemistries including liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. In cases of suspected IMARs, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue Opdualag depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). In general, if Opdualag requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose IMARs are not controlled with corticosteroid therapy. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below.

Immune-Mediated Pneumonitis

Opdualag can cause immune-mediated pneumonitis, which may be fatal. In patients treated with other PD-1/PD-L1 blocking antibodies, the incidence of pneumonitis is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.7% (13/355) of patients receiving Opdualag, including Grade 3 (0.6%), and Grade 2 (2.3%) adverse reactions. Pneumonitis led to permanent discontinuation of Opdualag in 0.8% and withholding of Opdualag in 1.4% of patients.

Immune-Mediated Colitis

Opdualag can cause immune-mediated colitis, defined as requiring use of corticosteroids and no clear alternate etiology. A common symptom included in the definition of colitis was diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies.

Immune-mediated diarrhea or colitis occurred in 7% (24/355) of patients receiving Opdualag, including Grade 3 (1.1%) and Grade 2 (4.5%) adverse reactions. Colitis led to permanent discontinuation of Opdualag in 2% and withholding of Opdualag in 2.8% of patients.

Immune-Mediated Hepatitis

Opdualag can cause immune-mediated hepatitis, defined as requiring the use of corticosteroids and no clear alternate etiology.

Immune-mediated hepatitis occurred in 6% (20/355) of patients receiving Opdualag, including Grade 4 (0.6%), Grade 3 (3.4%), and Grade 2 (1.4%) adverse reactions. Hepatitis led to permanent discontinuation of Opdualag in 1.7% and withholding of Opdualag in 2.3% of patients.

Immune-Mediated Endocrinopathies

Opdualag can cause primary or secondary adrenal insufficiency, hypophysitis, thyroid disorders, and Type 1 diabetes mellitus, which can be present with diabetic ketoacidosis. Withhold or permanently discontinue Opdualag depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information).

For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. In patients receiving Opdualag, adrenal insufficiency occurred in 4.2% (15/355) of patients receiving Opdualag, including Grade 3 (1.4%) and Grade 2 (2.5%) adverse reactions. Adrenal insufficiency led to permanent discontinuation of Opdualag in 1.1% and withholding of Opdualag in 0.8% of patients.

Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism; initiate hormone replacement as clinically indicated. Hypophysitis occurred in 2.5% (9/355) of patients receiving Opdualag, including Grade 3 (0.3%) and Grade 2 (1.4%) adverse reactions. Hypophysitis led to permanent discontinuation of Opdualag in 0.3% and withholding of Opdualag in 0.6% of patients.

Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism; initiate hormone replacement or medical management as clinically indicated. Thyroiditis occurred in 2.8% (10/355) of patients receiving Opdualag, including Grade 2 (1.1%) adverse reactions. Thyroiditis did not lead to permanent discontinuation of Opdualag. Thyroiditis led to withholding of Opdualag in 0.3% of patients. Hyperthyroidism occurred in 6% (22/355) of patients receiving Opdualag, including Grade 2 (1.4%) adverse reactions. Hyperthyroidism did not lead to permanent discontinuation of Opdualag. Hyperthyroidism led to withholding of Opdualag in 0.3% of patients. Hypothyroidism occurred in 17% (59/355) of patients receiving Opdualag, including Grade 2 (11%) adverse reactions. Hypothyroidism led to the permanent discontinuation of Opdualag in 0.3% and withholding of Opdualag in 2.5% of patients.

Monitor patients for hyperglycemia or other signs and symptoms of diabetes; initiate treatment with insulin as clinically indicated. Diabetes occurred in 0.3% (1/355) of patients receiving Opdualag, a Grade 3 (0.3%) adverse reaction, and no cases of diabetic ketoacidosis. Diabetes did not lead to the permanent discontinuation or withholding of Opdualag in any patient.

Immune-Mediated Nephritis with Renal Dysfunction

Opdualag can cause immune-mediated nephritis, which is defined as requiring use of steroids and no clear etiology. In patients receiving Opdualag, immune-mediated nephritis and renal dysfunction occurred in 2% (7/355) of patients, including Grade 3 (1.1%) and Grade 2 (0.8%) adverse reactions. Immune-mediated nephritis and renal dysfunction led to permanent discontinuation of Opdualag in 0.8% and withholding of Opdualag in 0.6% of patients.

Withhold or permanently discontinue Opdualag depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information).

Immune-Mediated Dermatologic Adverse Reactions

Opdualag can cause immune-mediated rash or dermatitis, defined as requiring use of steroids and no clear alternate etiology. Exfoliative dermatitis, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and Drug Rash with eosinophilia and systemic symptoms has occurred with PD-1/L-1 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes.

Withhold or permanently discontinue Opdualag depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information).

Immune-mediated rash occurred in 9% (33/355) of patients, including Grade 3 (0.6%) and Grade 2 (3.4%) adverse reactions. Immune-mediated rash did not lead to permanent discontinuation of Opdualag. Immune-mediated rash led to withholding of Opdualag in 1.4% of patients.

Immune-Mediated Myocarditis

Opdualag can cause immune-mediated myocarditis, which is defined as requiring use of steroids and no clear alternate etiology. The diagnosis of immune-mediated myocarditis requires a high index of suspicion. Patients with cardiac or cardio-pulmonary symptoms should be assessed for potential myocarditis. If myocarditis is suspected, withhold dose, promptly initiate high dose steroids (prednisone or methylprednisolone 1 to 2 mg/kg/day) and promptly arrange cardiology consultation with diagnostic workup. If clinically confirmed, permanently discontinue Opdualag for Grade 2-4 myocarditis.

Myocarditis occurred in 1.7% (6/355) of patients receiving Opdualag, including Grade 3 (0.6%), and Grade 2 (1.1%) adverse reactions. Myocarditis led to permanent discontinuation of Opdualag in 1.7% of patients.

Other Immune-Mediated Adverse Reactions

The following clinically significant IMARs occurred at an incidence of <1% (unless otherwise noted) in patients who received Opdualag or were reported with the use of other PD-1/PD-L1 blocking antibodies. Severe or fatal cases have been reported for some of these adverse reactions: Cardiac/Vascular: pericarditis, vasculitis; Nervous System: meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barr syndrome, nerve paresis, autoimmune neuropathy; Ocular: uveitis, iritis, and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other IMARs, consider a Vogt-Koyanagi-Haradalike syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss; Gastrointestinal: pancreatitis including increases in serum amylase and lipase levels, gastritis, duodenitis; Musculoskeletal and Connective Tissue: myositis/polymyositis, rhabdomyolysis (and associated sequelae including renal failure), arthritis, polymyalgia rheumatica; Endocrine: hypoparathyroidism; Other (Hematologic/Immune): hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection.

Infusion-Related Reactions

Opdualag can cause severe infusion-related reactions. Discontinue Opdualag in patients with severe or life-threatening infusion-related reactions. Interrupt or slow the rate of infusion in patients with mild to moderate infusion-related reactions. In patients who received Opdualag as a 60-minute intravenous infusion, infusion-related reactions occurred in 7% (23/355) of patients.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/PD-L1 receptor blocking antibody. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1/PD-L1 blockade and allogeneic HSCT.

Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/PD-L1 receptor blocking antibody prior to or after an allogeneic HSCT.

Embryo-Fetal Toxicity

Based on its mechanism of action and data from animal studies, Opdualag can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Opdualag for at least 5 months after the last dose of Opdualag.

Lactation

There are no data on the presence of Opdualag in human milk, the effects on the breastfed child, or the effect on milk production. Because nivolumab and relatlimab may be excreted in human milk and because of the potential for serious adverse reactions in a breastfed child, advise patients not to breastfeed during treatment with Opdualag and for at least 5 months after the last dose.

Serious Adverse Reactions

In Relativity-047, fatal adverse reaction occurred in 3 (0.8%) patients who were treated with Opdualag; these included hemophagocytic lymphohistiocytosis, acute edema of the lung, and pneumonitis. Serious adverse reactions occurred in 36% of patients treated with Opdualag. The most frequent serious adverse reactions reported in 1% of patients treated with Opdualag were adrenal insufficiency (1.4%), anemia (1.4%), colitis (1.4%), pneumonia (1.4%), acute myocardial infarction (1.1%), back pain (1.1%), diarrhea (1.1%), myocarditis (1.1%), and pneumonitis (1.1%).

Common Adverse Reactions and Laboratory Abnormalities

The most common adverse reactions reported in 20% of the patients treated with Opdualag were musculoskeletal pain (45%), fatigue (39%), rash (28%), pruritus (25%), and diarrhea (24%).

The most common laboratory abnormalities that occurred in 20% of patients treated with Opdualag were decreased hemoglobin (37%), decreased lymphocytes (32%), increased AST (30%), increased ALT (26%), and decreased sodium (24%).

Please see U.S. Full Prescribing Information for OPDUALAG.

OPDIVO U.S. INDICATIONS

OPDIVO (nivolumab), as a single agent, is indicated for the treatment of adult patients with unresectable or metastatic melanoma.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of adult patients with unresectable or metastatic melanoma.

OPDIVO (nivolumab) is indicated for the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

OPDIVO (nivolumab), in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors 4 cm or node positive) non-small cell lung cancer (NSCLC).

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

OPDIVO (nivolumab) is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC).

OPDIVO (nivolumab), in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

OPDIVO (nivolumab) is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

OPDIVO (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO (nivolumab) is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.

OPDIVO (nivolumab) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

OPDIVO (nivolumab), as a single agent, is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC.

OPDIVO (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

OPDIVO (nivolumab) is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.

OPDIVO (nivolumab) is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT).

OPDIVO (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).

OPDIVO (nivolumab), in combination with fluoropyrimidine- and platinum- containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.

IMPORTANT SAFETY INFORMATION

Severe and Fatal Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions listed herein may not include all possible severe and fatal immune-mediated adverse reactions.

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. While immune-mediated adverse reactions usually manifest during treatment, they can also occur after discontinuation of OPDIVO or YERVOY. Early identification and management are essential to ensure safe use of OPDIVO and YERVOY. Monitor for signs and symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and periodically during treatment with OPDIVO and before each dose of YERVOY. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). In general, if OPDIVO or YERVOY interruption or discontinuation is required, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below.

Immune-Mediated Pneumonitis

OPDIVO and YERVOY can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. In patients receiving OPDIVO monotherapy, immune-mediated pneumonitis occurred in 3.1% (61/1994) of patients, including Grade 4 (<0.1%), Grade 3 (0.9%), and Grade 2 (2.1%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated pneumonitis occurred in 7% (31/456) of patients, including Grade 4 (0.2%), Grade 3 (2.0%), and Grade 2 (4.4%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated pneumonitis occurred in 3.9% (26/666) of patients, including Grade 3 (1.4%) and Grade 2 (2.6%). In NSCLC patients receiving OPDIVO 3 mg/kg every 2 weeks with YERVOY 1 mg/kg every 6 weeks, immune-mediated pneumonitis occurred in 9% (50/576) of patients, including Grade 4 (0.5%), Grade 3 (3.5%), and Grade 2 (4.0%). Four patients (0.7%) died due to pneumonitis.

In Checkmate 205 and 039, pneumonitis, including interstitial lung disease, occurred in 6.0% (16/266) of patients receiving OPDIVO. Immune-mediated pneumonitis occurred in 4.9% (13/266) of patients receiving OPDIVO, including Grade 3 (n=1) and Grade 2 (n=12).

Immune-Mediated Colitis

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Bristol Myers Squibb Receives European Commission Approval for LAG-3-Blocking Antibody Combination, Opdualag (nivolumab and relatlimab), for the...

HR/VP Blog Post For decades, Somalia has suffered from beinga failed state and the current drought is making things worse. The EU is providingeconomic and humanitarian support to the country while our crisis management missions are helping to stabilise the security situation in a region that is of critical importance for Europes security. During my recent visit, I could see first-hand how our operations make a key contribution to maritime and wider security.

Somalia is located in theHorn of Africaand has the longest coastline onAfrica's mainland. For more than 30 years, it has been suffering from an ongoing humanitarian crisis and enduring political and social instability. The poverty rate of the 17 million population is around 70%; more than 50% are illiterate; and the average life expectancy is just 48 years. In recent years, the humanitarian situation has worsened further, due to a severe a drought and the risk of famine (the UN justsaid this weekthat hunger levels leave more than 500,000 children at risk of dying) and climate change affecting above all the lives of the most vulnerable, plus the lingering impact of COVID-19 and enduring conflicts. Finally, Russias war of aggression against Ukraine has further increased food insecurity with soaring food and fuel prices.

Why does this matter for Europe, given that Somalia seems so far away? To start, because around 40% of world shipping lanes and 25% of the EU maritime supply transit through the Gulf of Aden. Although piracy has been largely suppressed through international efforts, and above all the EU Operation Atalanta, it remains an underlying threat to maritime security including illegal trafficking and illicit trade. And because international terrorism threatens us all if we dont tackle it. The security situation remains highly volatile, with the terrorist groups Al-Shabaab and Daesh remaining active, as illustrated by the attack against the Hayat hotel in Mogadishu last August, with 20 persons killed and 120 injured.

That is why . The European Union needs to sustain its efforts in this part of the world, as elsewhere, to promote stability and security. And this is what we have been doing. From 2014 to 2022, the EU has invested more than 3.5 billion to support Somalias political, security and economic reform efforts and to address the humanitarian situation. We do so through humanitarian aid and cooperation programs on governance and the rule of law, peace-building, social inclusion and education, and on resilience and adaptation to climate change.

Crucially, we support Somali through three Common Security and Defence Policy (CSDP) missions to support peace and stability in the country and to help it to be able to take full ownership again for its own security:

Last Sunday I met Somalias President Hassan Sheikh Mohamud, who has been elected by members of Parliament in May 2022 (the new Cabinet was only appointed in August 2022). I also visited our two land-based CSDP missions and the Naval Force Operation Atalanta flagship, the Spanish frigate Numancia, which is patrolling the Somali coast.

Atalanta was the first EU naval operation ever, launched in 2008 and it has made a big difference in the fight against piracy. Indeed, it is one of the most remarkable success stories of the CSDP. Beyond piracy, it is now also engaged in other maritime security challenges, like the fight against narco- and arms-trafficking and illegal fishing.

Atalanta has turned into a maritime security actor of reference, offering a platform to develop our partnerships and for joint exercises with India, Indonesia, Oman and Japan. The operation is our main asset in the Indian Ocean, protecting freedom of navigation and demonstrating the EU's ability and commitment to enforce a rules-based order. It has been a pioneer shaping the maritime dimension of the CSDP and that continues to do this.

However, while Atalanta is a success, it is fair to recognise that our operations EUTM and EUCAP Somalia on shore have achieved only limited results. The Somali National Army (SNA), coast guards and police continue to face considerable force generation and efficiency challenges and we did not progress to the extent we had wished for, in terms of providing capacity building through advice and training to Somali authorities. However, having trained 8,000 Somali military so far, we will continue to do so and the SNA has already increased its capacity to train its personnel by itself.

We do this as part of wider efforts of the international community. The African Union Transition Mission (ATMIS) has an UN mandate that authorises AU states to deploy some 19,000 uniformed personnel in the country and the EU is the missions main financial supporter. Other countries are also active, with for instance Turkey running a big training mission and controlling the port of Mogadishu.

Visiting the missions and speaking to our soldiers and trainers, gave me first-hand insight on how our staff work on the ground, how they bring our security and defence policy to life. I praised our staff for their hard work and commitment in Mogadishu, as well as in Hargeisa, Garowe and Berbera. This work, far from home and in often very tough and difficult living conditions, takes courage and resilience and the dedication of our people in the field is a key element to promote and protect the EUs values and interests. It a fundamental work, to preserve regional security and to demonstrate that the EU is Africas most reliable partner, supporting African peace efforts with in eleven missions across the continent.

We intend to continue to strengthen the Somali security institutions while diminishing gradually our support. The aim is that Somalia takes full ownership for its own security by the end of 2024. Iassured President Hassan Sheikh Mohamudthat our missions would stand by the army, the police and the coast guards to help them fulfil this objective. I also acknowledged the new leadership's efforts to promote economic and social reform and advance state-building in cooperation with federal member states underlining that indeed cooperation between the federal government and the federal member states is crucial.

However, I also stressed that we are moving towards a more transactional partnership with the Somali authorities. EU support cannot be taken for granted and European citizens need to see that our engagement in Somalia bears fruit. For that, Somalias leaders have to deliver a more secure, stable and democratic Somalia, delivering basic services and security to its people.

See more here:
Building Somalia's state and security and stabilising the Horn of Africa | EEAS Website - EEAS

Looking at the major challenges ahead, we, the Ministers for European Affairs of France, Germany and Poland reaffirm our joint commitment to take responsibility, to promote answers meeting our citizens concerns, to strengthen resilience of the European Union and to secure our European future based on EU common founding values.

Russias war of aggression against Ukraine has most brutally attacked peace and security in Europe. This war is an attack on our European model based on freedom, democracy and a rules-based order. A firm and united reaction of the European Union and its Member States condemning the war, offering shelter to refugees, adopting restrictive measures against Russia and providing support to Ukraine notably in the form of significant military assistance, has been and remains key. It is crucial to continue on this path since the European assistance is essential for Ukraine to continue its fight in defence of its sovereignty and European values. We recognize that helping sustain Ukrainian forces in the long run entails going beyond the provision of equipment, notably by setting up a dedicated European training and assistance mission in the EU for Ukrainian forces that would also ensure maintenance and repair of military equipment.

France, Germany and Poland also reiterate their support for Ukraines legal proceedings against the Russian Federation including by intervening in Ukraines proceedings before the International Court of Justice under the 1948 Convention on the Prevention and Punishment of the Crime of Genocide, which seek to establish that Russia has no lawful basis to take military action in Ukraine on the basis of false allegations of genocide. Moreover, Russia is using hunger as a weapon and taking the world hostage with a food security crisis it has caused and exacerbated. We strongly support the EU initiative EU Solidarity Lanes which helps to export Ukraine grain as well as other products and cherish the special commitment of all EU Member States neighboring Ukraine in this regard. France, Germany and Poland reiterate their firm stance with Ukraine and continuous strong support for Ukraines overall economic, military, social and financial resilience. The European Union civil protection mechanism [EUCPM] proofs to be an important tool for coordinated support and united action beyond its borders. We stay committed to continue our humanitarian assistance for the people of Ukraine. As Russias war of aggression against Ukraine marks a fundamental turning point in EU-Russia relations, we need to re-define key guiding principles of the European Unions policy towards Russia. We also advocate for a strategic approach involving international partners to address the reconstruction of Ukraine in a concerted and sustainable manner. We welcome the agreement by EU Finance Ministers to provide an additional macro financial assistance package of 5 billion Euro, as a clear sign of the EUs continued commitment to support Ukraines resilience and call to further step up our endeavors in order to reach an expeditious agreement on the remainder of the European Councils 9 billion euro European Councils pledge.

Additionally, our countries are convinced that we have to join efforts to enable the European Union to defend our core values and secure stability against challenges from the outside. Referring to the European Council Conclusions of 23 and 24 June 2022 - which recognized the European perspective of Ukraine, Moldova and Georgia and granted the status of candidate country to Ukraine and Moldova - , France, Germany and Poland jointly state that enlargement of the European Union is an important element in this context. Thus, we have discussed ways to support these countries on their reform path to meet the Copenhagen criteria. We have also agreed on the need to further reflect on internal reforms and compromise solutions to ensure the European Unions capacity to maintain and deepen its own development. In this context, we also see merit in following up on and discussing the final proposals of the Conference on the Future of Europe. Poland, France and Germany attach great importance to the integrity of national and European elections and better resilience against disinformation and interference. We therefore support the Commissions proposal for a regulation on the transparency and targeting of political advertising. We also support a coherent electoral law to be in place for the next European elections 2024.

We reaffirm our full and unequivocal commitment to the EU membership perspective for the six Western Balkans countries. France, Germany and Poland welcome progress reached in the accession process of Albania and North Macedonia. We stand ready to support the reform processes in the region, where progress, notably in the area of rule of law and the fight against corruption, as well as in reconciliation and resolving outstanding bilateral and regional disputes, is of particular importance. We are concerned about the political crisis in Bosnia and Herzegovina and call on all parties to ensure fair and free elections on 2 October 2022. We fully support the EU-led Kosovo-Serbia dialogue and stress the need for a comprehensive agreement that allows for Kosovo and Serbia to advance on their respective European paths and contributes to the stability in the region. We call for progress regarding the visa liberalization for Kosovo. Our countries are strongly committed to the Berlin Process as an additional means to foster regional cooperation and EU accession of the Western Balkan countries; we highlight the importance of implementing the historic decision by the six Western Balkan countries to create a Common Regional Market. Given the importance we attach to the region and as a sign of our joint support, we have agreed on a trilateral visit to this region and advocate for further strengthening the ties between the EU and the Western Balkans.

France, Germany and Poland share the view that fostering a wider area of stability and economic prosperity and strengthening resilience in Europe is in the EUs core interest. Thus, we welcome the objective to foster political dialogue and cooperation through a European Political Community that acts as a broader platform to address issues of common interest for European countries across the continent, as discussed at the European Council of 23 June 2022. Reaffirming that this shall not generate a substitute to the EU enlargement process nor double existing institutions, alliances or platforms in Europe, we jointly look forward to continuing this strategic discussion with our EU partners and welcome the holding of a first meeting on 6 October 2022 in Prague.

Russias war of aggression and use of energy as a geopolitical weapon, notably the stop or significant reduction of gas supplies to certain member states, has raised concerns of people across the EU regarding a possible gas shortage paired with already high energy prices. We share the view that security of supply for our countries, affordability of energy for citizens and economies, and climate and energy transition in line with the Paris Agreement get ever more urgent.

While France, Germany and Poland agree on the need to join efforts also in countering Russian disinformation on the cause of this crisis, we advocate for a concerted approach based on the spirit of European solidarity to develop a successful answer to this immediate and essential challenge to our economies and societies.

We, the Ministers for European Affairs of France, Germany and Poland, aspire the Weimar Triangle, founded as a means to strengthening links between our people and countries in all aspects of life as well as promoting sustainable common structures in Europe, to be a driving force in developing answers to the challenges Europe is confronted with within and beyond its borders today.

Thus, we will continue close political coordination, look forward to our next meeting and will further strengthen civil society cooperation with concrete projects and exchanges to foster bridges and strengthen unity in Europe. We will strive to further develop cooperation between our civil societies, especially between the youth of our three countries, as well as cultural projects and European memory and reconciliation projects, as well as exchanges between young diplomats. We commit ourselves to support decentralized cooperation and we welcome the fact that the cooperation in the Weimar format between our cities and communities has been given new impetus with the reception of refugees from Ukraine. We encourage meetings of young people in the Weimar format with Ukrainian refugees hosted in our countries on EU-related topics and Ukraine's accession to the EU.

Read more:
Joint statement by the Ministers for European Affairs of the Weimar Triangle - Auswrtiges Amt

European Union flags flutter outside the EU Commission headquarters in Brussels, Belgium June 17, 2022. REUTERS/Yves Herman

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BUDAPEST, Sept 6 (Reuters) - Hungary will create an anti-corruption authority and a working group involving non-government organisations to oversee the spending of European Union funds, the government said in a decree in its official gazette late on Monday.

The move by Budapest is aimed at unlocking EU funds as nationalist Prime Minister Viktor Orban's government is locked in battles with Brussels over corruption, migration, LGBTQ rights and democratic standards.

The European Commission has been withholding its approval for Hungary to draw on money meant to help lift economies from the COVID-19 pandemic, accusing Orban's government of undermining the rule of law.

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Hungary also faces financial penalties from the European Union over the same rule of law issues, including public tender procedures that fall short on anti-corruption safeguards.

The government will introduce a bill in parliament creating an independent anti-corruption authority by Sept. 30 and expects it to be set up by Nov. 21.

The new body will step in if Hungarian authorities do not take sufficient steps to "prevent, investigate and fix cases of fraud, conflict of interest, corruption or other crimes and abuses" as European Union funds are spent, the decree said.

The government will also create an anti-corruption working group to advise the authority. Half the members of the group will be government delegates and the others will be representatives of non-governmental organisations.

Orban's government has come under increased pressure in recent months to strike a deal with Brussels as the forint currency hit new lows and inflation keeps surging.

PM Orban's chief of staff said last month that Hungary will amend by the end of October several laws criticised by the European Commission if an agreement on financial aid is reached with the EU executive.

Gergely Gulyas also said Hungary would create a "stricter than ever" and most transparent system for overseeing the use of EU funds and procurement contracts. read more

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Reporting by Anita Komuves, editing by Ed Osmond

Our Standards: The Thomson Reuters Trust Principles.

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Hungary to set up anti-corruption body in bid to unlock EU funds - Reuters