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Bristol-Myers to Seek U.S. Approval for Immuno-Oncology Drug

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Bristol-Myers Squibb Company (BMY - Free Report) announced that it intends to seek FDA approval for its high potential immuno-oncology drug Opdivo (nivolumab, a PD-1 immune checkpoint inhibitor) for the advanced melanoma indication in previously treated patients by Sep 30, 2014. The news of the impending filing boosted Bristol-Myers’ shares.

Bristol-Myers said in its press release that it will seek FDA approval for the advanced melanoma indication on the basis of positive results from a phase III study (Checkmate -037). The patients in the trial were previously treated with Bristol-Myers’ marketed skin cancer drug Yervoy and with a BRAF inhibitor regimen in case they were BRAF-mutation positive. We note that Opdivo was approved in Japan earlier this month for treating patients with unresectable melanoma.

Following the Japanese approval, Opdivo became the first PD-1 immune checkpoint inhibitor to gain approval. Ono Pharmaceutical has the rights to commercialize the treatment in Japan as per a 2011 agreement with Bristol-Myers.

We note that another anti-PD-1 antibody, Merck’s (MRK - Free Report) pembrolizumab (MK-3475), is under FDA review for treating unresectable or metastatic melanoma in patients pretreated with Yervoy. A decision is expected by Oct 28, 2014. Hence it is likely that Merck will be the first company to receive FDA approval for an anti-PD-1 therapy. The candidate is also under review in the EU.
Bristol-Myers is already seeking FDA approval for Opdivo in another oncology indication, namely, third-line squamous cell non-small cell lung cancer. The biopharmaceutical major initiated a rolling submission for the indication based on results from the 063 study. Bristol-Myers expects to complete the rolling submission by Dec 31, 2014.

Approval of Opdivo for the above indications 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. Opdivo is also being studied in other oncology indications as well, such as, renal cell carcinoma, head and neck cancer, glioblastoma and non-Hodgkin lymphoma.

Bristol-Myers carries a Zacks Rank #3 (Hold). Better-ranked stocks in the health care sector include Biogen Idec (BIIB - Free Report) and The Medicines Co. (MDCO - Free Report) . Both the stocks sport a Zacks Rank #1 (Strong Buy).

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