Bristol-Myers Squibb CompanyBMY announced that the FDA has cleared its intravenous human programmed death receptor-1 (PD-1) blocking antibody, Opdivo, for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
We note that the latest approval for RCC, in patients who received prior anti-angiogenic therapy, marks the fifth label expansion for Opdivo across three distinct tumor types. Opdivo is currently approved for the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor; and for the treatment of patients with metastatic non small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Apart from these, Opdivo is approved in combination with Yervoy for the treatment of patients with BRAF V600 wild-type, unresectable or metastatic melanoma.
Opdivo generated revenues of $305 million in the third quarter of 2015 as compared to $122 million in the previous quarter. The company continues to work on label expansion of the drug. Last year, Bristol-Myers inked a deal with Ono Pharmaceutical to jointly develop and commercialize Opdivo (both as monotherapy and in combination with other agents) in Japan, South Korea and Taiwan.
Currently, the anti-PD-1 therapy market also has Merck & Co. Inc.'s MRK Keytruda indicated for NSCLC and melanoma.
Bristol-Myers currently carries a Zacks Rank #3 (Hold). A couple of other well-ranked stocks in the health care sector are GW Pharmaceuticals plc GWPH and Biogen BIIB . While GW Pharma sports a Zacks Rank #1 (Strong Buy), Biogen holds a Zacks Rank #2 (Buy).
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