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 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.
The company plans to start shipping the drug in next few weeks.
Opdivo is being studied in several oncology indications, such as, renal cell carcinoma, head and neck cancer, glioblastoma and non-Hodgkin lymphoma. We note that Opdivo is already approved in Japan for treating patients with unresectable melanoma.
The candidate is under review in the EU for the advanced melanoma and non-small cell lung cancer (NSCLC) indications. The company is also looking to get Opdivo approved for NSCLC in the U.S.
Our Take
We are pleased with Opdivo gaining accelerated approval, which would strengthen Bristol-Myers’ position in the lucrative as well as highly sought-after immuno-oncology space. We expect investor focus to remain on updates regarding the high potential Opdivo.
We remind investors that in Sep 2014, Merck & Co.'s (MRK) Keytruda gained accelerated approval from the FDA for the treatment of patients suffering from advanced or unresectable melanoma who are no longer responding to other drugs. Keytruda was the first anti PD-1 drug to gain approval in the U.S.
Bristol-Myers carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Allergan (AGN) and Actavis (ACT), both carrying a Zacks Rank #2 (Buy).
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