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Bristol-Myers' Melanoma Combo Opdivo/Yervoy Gets FDA Nod

Zacks Equity Research

Bristol-Myers Squibb Company BMY announced that the combination of two of its immuno-oncology drugs, Opdivo and Yervoy, has been cleared by the FDA for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. The approval makes the Opdivo and Yervoy combination the first regimen of two immuno-oncology drugs.

The FDA granted accelerated approval to the Opdivo and Yervoy combination based on encouraging results from a phase II study (CheckMate - 069). Results revealed that patients treated with the combination regimen showed a much higher objective response rate (ORR) of 60% as compared to 11% in those under Yervoy monotherapy. This was also the primary endpoint of the study. Complete responses were also statistically higher in patients under the combination regimen as compared to those under Yervoy monotherapy. Continued approval for the melanoma indication depends on data from the confirmatory studies.

However, uptake of the combination regimen remains to be seen considering the high price tag. Recently, the biotech sector has been in the limelight, drawing a lot of criticism for its high-priced drugs.

Bristol-Myers is also looking to get Opdivo – Yervoy approved for patients with previously untreated advanced melanoma. The FDA has accepted the company’s supplemental biologics license application for the same and granted priority review. The FDA is expected to render a final decision by Jan 23, 2016. The company is also evaluating the combination for lung cancer.

Both Opdivo and Yervoy are currently approved for melanoma. Opdivo is also approved for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Opdivo generated revenues of $122 million in the second quarter of 2015 as compared to $40 million in the first quarter of 2015. Meanwhile, the company continues to work on the label expansion of the drug.

Bristol-Myers currently carries a Zacks Rank #3 (Hold). Some-better ranked stocks in the health care sector include Anika Therapeutics Inc. ANIK, Regeneron Pharmaceuticals, Inc. REGN and Eli Lilly and Company LLY. Both Regeneron and Anika hold a Zacks Rank #1 (Strong Buy), while Eli Lilly is a Zacks Rank #2 (Buy) stock.

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REGENERON PHARM (REGN): Free Stock Analysis Report
BRISTOL-MYERS (BMY): Free Stock Analysis Report
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