Bristol-Myers Squibb Company (BMY - Free Report) announced that the supplemental Biologics License Application (sBLA) for immuno-oncology drug Opdivo has been accepted with priority review by the FDA. The company is looking to add previously treated patients with non-squamous non-small cell lung cancer (NSCLC) to Opdivo’s label. The FDA is expected to render a decision on the product by Jan 2, 2016. Shares were up 2.4% on the news.
The FDA has granted Breakthrough Therapy designation to Opdivo for the above mentioned indication.
We note that Opdivo is currently approved as a monotherapy in two cancer indications – the treatment of patients with metastatic squamous NSCLC with progression on or after platinum-based chemotherapy and the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation-positive, a BRAF inhibitor.
Approval for non-squamous NSCLC will expand the product’s targeted patient population and boost the drug’s commercial potential.
Bristol-Myers is focused on boosting its immuno-oncology portfolio. Earlier this week, the company along with its partner AbbVie (ABBV - Free Report) announced that the BLA for immuno-oncology candidate Empliciti has been accepted with priority review by the FDA. Empliciti is being developed as a combination therapy for treatment-experienced patients suffering from multiple myeloma (read more: Bristol-Myers/AbbVie Cancer Drug Gets Priority Review).
In addition, the company acquired Flexus Biosciences for $1.25 billion and collaborated with Rigel Pharmaceuticals Inc. (RIGL - Free Report) in a deal worth more than $339 million, all to bolster its immuno-oncology pipeline.
Bristol-Myers currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Novo Nordisk (NVO - Free Report) , carrying a Zacks Rank #2 (Buy).
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