Bristol-Myers Squibb’s Opdivo Receives US FDA Approval For Gastric Cancer Treatment


Bristol-Myers Squibb has received approval from the US Food and Drug Administration for Opdivo in combination with fluoropyrimidine- and platinum-containing chemotherapy to treat gastric cancer. This includes patients with gastric cancer, gastroesophageal cancer, and esophageal adenocarcinoma.

Bristol-Myers Squibb’s (BMY) General Manager and Head, US, Oncology, Immunology, Cardiovascular, Adam Lenkowsky said, “We are focused on bringing transformative medicines to patients in need, and historically, there has been little progress for patients diagnosed with these metastatic gastroesophageal adenocarcinomas.”

Lenkowsky added, “As demonstrated in the Checkmate-649 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.” (See Bristol-Myers Squibb stock analysis on TipRanks)

In the Checkmate-649 trial, the drug was evaluated in combination with fluorouracil, leucovorin, and oxaliplatin or capecitabine and oxaliplatin, versus chemotherapy treatment alone. The combination reduced the risk of death by 20% and showed a 55% survival rate at one year.

Notably, the drug was reviewed under the FDA’s Real-Time Oncology Review (RTOR) program and also under the Project Orbis initiative. RTOR aims to ensure that treatments reach patients as early as possible. Orbis enables simultaneous review by regulators in Canada, Australia, Switzerland, and Brazil.

On April 10, Raymond James analyst Dane Leone reiterated a Buy rating on the stock but did not assign any price target.

Commenting on the results of Bristol-Myers Squibb’s Phase 3 Checkmate-816 trial of nivolumab for treating resectable NSCLC, Leone said, “The results today clearly indicate improvement in pCR, but our focus will look to the ongoing EFS primary endpoint and secondary endpoints which are pending follow up.”

Consensus on the Street is that Bristol-Myers is a Strong Buy based on 5 unanimous Buys. The average analyst price target of $77 implies upside potential of 17.6%. Shares have gained about 9.9% over the past year.

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