Opdivo as an injection combined with chemotherapy was cleared by the FDA to treat patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma, the company said.
The approval is based on a Phase 3 trial.
“Historically, there has been little progress for patients diagnosed with these metastatic gastroesophageal adenocarcinomas,” said Adam Lenkowsky, general manager of oncology at the New York company.
“As demonstrated in the … trial, Opdivo is the first and only immunotherapy combined with chemotherapy to deliver superior overall survival versus chemotherapy alone in first-line metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.”
BMY recently traded at $65.42, up 1.5%.
On Tuesday, Truist upgraded the pharmaceutical giant to buy from hold amid optimism about its drug pipeline. Truist analyst Gregg Gilbert also raised his price target to $74 a share from $66.
“We launched on U.S. major [pharmaceuticals] in October with an overall bullish view on the group, but we started with a hold rating on BMY pending greater visibility on key late-stage pipeline assets,” Gilbert wrote in a commentary. Since then, BMY has received three FDA clearances
Bristol Myers posted stronger-than-expected fourth-quarter earnings and boosted its full-year profit forecast, as sales linked to its 2019 purchase of Celgene continue to support growth.
Bristol Myers said non-GAAP earnings for the quarter totaled $1.46 a share, up 20% from the year-earlier quarter and 4 cents ahead of the Wall Street consensus forecast.