BMS’s Opdivo earns indication for gastric cancer
Opdivo is the first FDA-approved immunotherapy for the first-line treatment of gastric cancer.
FDA approved Bristol-Myers Squibb’s Opdivo (nivolumab), in combination with certain types of chemotherapy, for the initial treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma.
Opdivo is the first FDA-approved immunotherapy for the first-line treatment of gastric cancer. There are 21 indications for the drug across 12 types of cancer.
Related: New Cabometyx-Opdivo combination for renal cell carcinoma treatment
“Today’s approval is the first treatment in more than a decade to show a survival benefit for patients with advanced or metastatic gastric cancer who are being treated for the first time,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, in a press release.
There are approximately 28,000 new diagnoses of gastric cancer each year in the U.S. and with currently available therapy, overall survival is generally poor, FDA said. The survival rate for all stages is 32%, and the 5-year survival rate for advanced or metastatic gastric cancer is only 5%.
FDA’s approval was based on a randomized, multicenter, open-label trial of 1,581 patients with previously untreated advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma.
The median survival was 13.8 months for patients who received Opdivo plus chemotherapy compared to 11.6 months for patients who received chemotherapy alone.
Related: FDA clears Orgovyx, the first-of-its-kind prostate cancer treatment
In an exploratory analysis of all patients, 55% of patients on Opdivo in combination with chemotherapy were alive at one year versus 48% of patients on chemotherapy alone, BMS said in a press release.
The most common side effects of Opdivo in combination with chemotherapy include peripheral neuropathy (damage to the nerves outside of the brain and spinal cord), nausea, fatigue, diarrhea, vomiting, decreased appetite, abdominal pain, constipation and musculoskeletal pain.
Opdivo can cause immune-mediated side effects, including inflammation of healthy organs such as the lungs, colon, liver, endocrine glands, and kidneys.
Read more: FDA fast-tracks investigational leukemia treatment
FDA Advisory Committee Votes Down Sotagliflozin in Type 1 Diabetes and CKD
November 1st 2024Committee members said there was uncertainty around sotagliflozin in patients with kidney disease. The FDA is currently reviewing the oral therapy as an adjunct to insulin to help control glycemic levels in adults with type 1 diabetes and chronic kidney disease. The agency’s goal date is Dec. 20, 2024.
Read More
Using the 'Pathway' Approach to Shorten the Time Between Cancer Diagnosis and Treatment
November 16th 2022In this episode of Tuning In to the C-Suite, Briana Contreras, editor with Managed Healthcare Executive spoke with Dr. Yuri Fesko, oncologist and vice president of Medical Affairs at Quest Diagnostics. In the conversation, Dr. Fesko addressed the ongoing issue of long gaps of times between receiving a diagnosis for a type of cancer and finally getting the treatment for it. Dr. Fesko shared the benefits a number of sectors receive when treating patients sooner and the steps to get there.
Listen
