FDA green lights first immunotherapy as initial gastric cancer therapy

Bristol Myers Squibb’s (NYSE: BMY) closed up 1.6% at $65.46 on Friday, after the US pharma major bagged another indication for its blockbuster immuno-oncology drug Opdivo (nivolumab), and this came well ahead of the prescription drug user fee act (PDUFA) goal date for a decision on the immunotherapy regimen of May 25.

The US Food and Drug Administration approved Opdivo, which generated global sales of $7 billion in 2020, 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.

This is the first FDA-approved immunotherapy for the first-line treatment of gastric cancer. The FDA’s Oncology Center of Excellence director Dr Richard Pazdur, said Opdivo 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, adding that there are roughly 28,000 new diagnoses of gastric cancer a year in the USA.