FDA Accepts Bristol Myers (BMY) sBLAs for Opdivo Combo for ESCC

Bristol Myers Squibb BMY announced that the FDA has accepted the supplemental biologics license applications (“sBLAs”) for two combinations with Opdivo (nivolumab) –– one with Yervoy (ipilimumab) and the other with chemotherapy –– as potential first-line treatments for adults with esophageal squamous cell carcinoma (“ESCC”).

A decision from the FDA is anticipated on May 28, 2022.

The applications were based on encouraging data from a pivotal phase III CheckMate -648 study, which evaluated Opdivo-based combinations with chemotherapy alone in patients with unresectable advanced or metastatic ESCC.

Data from the study demonstrated that treatment with both Opdivo-based combinations achieved statistically significant and clinically meaningful overall survival in ESCC patients versus chemotherapy alone in both populations. Data from the study also demonstrated that the safety profiles of both combinations were consistent with the safety profile of the individual components.

Bristol Myers’ shares have declined 3.5% so far this year in comparison with the industry’s 2.6% decrease.

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Esophageal cancer is one of the most frequently diagnosed cancers. ESCC is a common form of esophageal cancer. It accounts for 85% of all esophageal cancers. Per the company, approximately 600,000 new cases of esophageal cancer were reported globally in 2020. A potential regulatory approval will give a further boost to its top line.

Please note that Opdivo is already approved for treating patients with unresectable advanced, recurrent or metastatic ESCC after prior chemotherapy. Further, the combination of Opdivo and Yervoy is already approved for the treatment of multiple cancer indications that include melanoma, non-small cell lung cancer, malignant pleural mesothelioma and renal cell carcinoma.

Opdivo has already received global approvals for the treatment of multiple types of cancer. The drug continues to grow, and expand into new indications as well as global markets. Last week, the company announced that the FDA has accepted its biologics license application for the fixed-dose combination of LAG-3-blocking antibody relatlimab and immuno-oncology Opdivo, administered as a single infusion, for the treatment of adult and pediatric patients with unresectable or metastatic melanoma.

Opdivo faces stiff competition from Merck’s MRK Keytruda, which is also approved for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction carcinoma, either as a monotherapy or in combination with chemotherapy.

Bristol Myers Squibb Company Price

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Zacks Rank & Stocks to Consider

Bristol Myers currently carries a Zacks Rank #3 (Hold). A couple of better ranked stocks in the same sector are Regeneron Pharmaceuticals REGN and Vertex Pharmaceuticals VRTX. While Regeneron carries a Zacks Rank #1 (Strong Buy) at present, Vertex holds a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Regeneron’s earnings per share estimates for 2021 have increased from $49.91 to $61.41 in the past 60 days. The same for 2022 has risen from $40.91 to $46.73 over the same period. The stock has rallied 28.1% in the year so far.

Vertex’s earnings per share estimates for 2021 have increased from $11.87 to $12.37 in the past 60 days. The same for 2022 has risen from $12.65 to $13.13 over the same period.

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.