Bristol-Myers Squibb Company BMY announced that the FDA has issued a Complete Response Letter (CRL) for its intravenous human programmed death receptor-1 (PD-1) blocking antibody, Opdivo, as a single agent for the treatment of previously untreated patients, specifically those with BRAF V600 mutation positive unresectable or metastatic melanoma.
In its CRL, the FDA indicated the need for additional data in the BRAF mutated patient population. The company plans to work closely with the FDA to address the issue.
We remind investors that only last week, the FDA approved Opdivo as a single agent for the treatment of patients with BRAF wild-type unresectable or metastatic melanoma and for the treatment of patients with advanced renal cell carcinoma who received prior anti-angiogenic therapy. Apart from that, Opdivo is 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. It is also approved for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Moreover, Opdivo is approved in combination with Yervoy for the treatment of patients with BRAF V600 wild-type, unresectable or metastatic melanoma.
The drug generated revenues of $305 million in the third quarter of 2015 compared with $122 million in the previous quarter. The company continues to work on the label expansion of the drug. A supplemental Biologics License Application for Opdivo in BRAF V600 mutation positive unresectable or metastatic melanoma is under regulatory review in the U.S.
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 better-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 has a Zacks Rank #2 (Buy).
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