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Bristol-Myers' Opdivo/Yervoy sBLA for RCC Accepted by FDA
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Bristol-Myers Squibb Company (BMY - Free Report) announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for priority review of Opdivo plus Yervoy (ipilimumab) for the treatment of intermediate- and poor-risk patients with advanced renal cell carcinoma (RCC).
We note that the FDA had granted Breakthrough Therapy Designation for this application which will expedite the development and review of the same.
The FDA will make a decision by Apr 16, 2018.
The application is based on data from the phase III study, Checkmate -214 study. The study was stopped ahead of schedule based on the recommendation of an independent Data Monitoring Committee following a planned interim analysis of overall survival. The study evaluated the combination of Opdivo plus Yervoy versus Sutent for previously untreated advanced or metastatic RCC.
The study met the co-primary endpoints of improved overall survival and objective response rate compared to Sutent in intermediate- and poor-risk patients. Although the combination demonstrated an improvement in progression-free survival relative to Sutent, another co-primary endpoint, it did not reach statistical significance.
So far this year, Bristol-Myers’ shares have rallied 9.2% compared with the industry gain of 20.2%.
We note that Opdivo is already approved for a number of indications. These include classical Hodgkin lymphoma, recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after platinum-based therapy. Additionally, it is approved as a monotherapy for the treatment of squamous cell carcinoma of the head and neck in adults progressing on or after platinum-based therapy.
Opdivo is also approved for intravenous use for patients with hepatocellular carcinoma, who have been previously treated with Nexavar. The drug received approval for liver and colorectal cancers.
Meanwhile, the company continues to evaluate Opdivo alone or in combination therapies with Yervoy and other anti-cancer agents. Label expansion of the drug into additional indications will give the product an access to a higher patient population and increase its commercial potential.
However, Opdivo is facing competitive challenges in the United States. With the FDA approving Merck’s (MRK - Free Report) Keytruda, for the first-line treatment of metastatic non-squamous NSCLC, the company is expected to suffer further loss of market share.
The virology business is also under pressure. The company is also looking to counter generic threat for key drugs through deals and acquisitions. The company recently entered into a deal with AbbVie, Inc. (ABBV - Free Report) and Halozyme Therapeutics, Inc. (HALO - Free Report) .
A medical advance is now at the flashpoint between theory and realization. Billions of dollars in research have poured into it. Companies are already generating substantial revenue, and even more wondrous products are in the pipeline.
Cures for a variety of deadly diseases are in sight, and so are big potential profits for early investors. Zacks names 5 stocks to buy now.
Image: Bigstock
Bristol-Myers' Opdivo/Yervoy sBLA for RCC Accepted by FDA
Bristol-Myers Squibb Company (BMY - Free Report) announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for priority review of Opdivo plus Yervoy (ipilimumab) for the treatment of intermediate- and poor-risk patients with advanced renal cell carcinoma (RCC).
We note that the FDA had granted Breakthrough Therapy Designation for this application which will expedite the development and review of the same.
The FDA will make a decision by Apr 16, 2018.
The application is based on data from the phase III study, Checkmate -214 study. The study was stopped ahead of schedule based on the recommendation of an independent Data Monitoring Committee following a planned interim analysis of overall survival. The study evaluated the combination of Opdivo plus Yervoy versus Sutent for previously untreated advanced or metastatic RCC.
The study met the co-primary endpoints of improved overall survival and objective response rate compared to Sutent in intermediate- and poor-risk patients. Although the combination demonstrated an improvement in progression-free survival relative to Sutent, another co-primary endpoint, it did not reach statistical significance.
So far this year, Bristol-Myers’ shares have rallied 9.2% compared with the industry gain of 20.2%.
We note that Opdivo is already approved for a number of indications. These include classical Hodgkin lymphoma, recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after platinum-based therapy. Additionally, it is approved as a monotherapy for the treatment of squamous cell carcinoma of the head and neck in adults progressing on or after platinum-based therapy.
Opdivo is also approved for intravenous use for patients with hepatocellular carcinoma, who have been previously treated with Nexavar. The drug received approval for liver and colorectal cancers.
Meanwhile, the company continues to evaluate Opdivo alone or in combination therapies with Yervoy and other anti-cancer agents. Label expansion of the drug into additional indications will give the product an access to a higher patient population and increase its commercial potential.
However, Opdivo is facing competitive challenges in the United States. With the FDA approving Merck’s (MRK - Free Report) Keytruda, for the first-line treatment of metastatic non-squamous NSCLC, the company is expected to suffer further loss of market share.
The virology business is also under pressure. The company is also looking to counter generic threat for key drugs through deals and acquisitions. The company recently entered into a deal with AbbVie, Inc. (ABBV - Free Report) and Halozyme Therapeutics, Inc. (HALO - Free Report) .
Zacks Rank & Stock to Consider
Bristol-Myers currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Investor Alert: Breakthroughs Pending
A medical advance is now at the flashpoint between theory and realization. Billions of dollars in research have poured into it. Companies are already generating substantial revenue, and even more wondrous products are in the pipeline.
Cures for a variety of deadly diseases are in sight, and so are big potential profits for early investors. Zacks names 5 stocks to buy now.
Click here to see them >>