Bristol-Myers Oncology Drug Opdivo Label Expanded in U.S.

Bristol-Myers Squibb Company BMY announced that the FDA has cleared its intravenous human programmed death receptor-1 (PD-1) blocking antibody, Opdivo, for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.

We note that last month, the company had announced that Bristol-Myers’s Biologics Licensing Application (BLA) for Opdivo has been accepted by the FDA for the treatment of patients suffering from advanced squamous NSCLC who have undergone prior therapy. The FDA granted priority review for the application and an action from the agency was expected by Jun 22, 2015. The approval came in much ahead of the expected date.

Bristol-Myers had filed for Opdivo’s approval in this indication on the basis of a phase II, single-arm, open-label study, CheckMate – 063 and an open-label, randomized phase III study, CheckMate – 017, which was stopped early because an assessment conducted by the independent Data Monitoring Committee concluded that the study met its primary endpoint. The product is in the registrational process in Europe for advanced melanoma and advanced squamous NSCLC.

We remind investors that Opdivo was approved in the U.S. for the treatment of patients suffering from unresectable or metastatic melanoma and disease progression following Yervoy and, if BRAF V600 mutation positive, a BRAF inhibitor. Opdivo gained accelerated approval for the melanoma indication based on tumor response rate and the durability of response. Full approval for this indication depends on verification and description of clinical benefit in the confirmatory trials (read more: Bristol-Myers Oncology Drug Opdivo Receives FDA Approval).

Opdivo generated $6 million in the fourth quarter of 2014. We expect investor focus to remain on updates regarding the high potential Opdivo.

Bristol-Myers carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Cytokinetics, Inc. CYTK, ANI Pharmaceuticals, Inc. ANIP and Horizon Pharmaceuticals HZNP. All three stocks carry a Zacks Rank #1 (Strong Buy).