Bristol Myers Squibb BMY announced that the FDA accepted its supplemental Biologics License Application (sBLA) for its blockbuster immuno-oncology drug Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for another indication. The company is seeking approval of the combination when administered concomitantly with a limited course of chemotherapy for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.
The agency granted this application a Priority Review, with a target action date of Aug 6, 2020. The FDA has also granted the application a Fast Track designation.
In addition, the European Medicines Agency (EMA) validated a type II variation application for Opdivo plus Yervoy in combination with limited chemotherapy for the same indication. The EMA can now begin its centralized review process.
The applications were based on results from the phase III CheckMate -9LA study, which met its primary endpoint of superior overall survival (OS) at a pre-specified interim analysis (announced in October 2019).
The company is looking forward to bringing the first and only dual immunotherapy plus limited chemotherapy regimen to patients at the earliest.
We remind investors that the company’s BLA for Opdivo plus Yervoy for the first-line treatment of patients with metastatic or recurrent NSCLC with no EGFR or ALK genomic tumor aberrations is currently under review in the United States, with an FDA action date of May 15, 2020. This sBLA was based on data from Part 1 of the phase III CheckMate -227 trial.
This is a very important indication for Opdivo, given the market potential. The drug’s sales were sluggish in the fourth quarter as it faces stiff competition from Merck’s MRK Keytruda and Roche’s RHHBY Tecentriq. AstraZeneca’s AZN Imfinzi is also approved for lung cancer.
Bristol-Myers’ shares have lost 9.2% so far this year compared with the industry’s decline of 7%.
However, in January, the company withdrew its European application for Opdivo plus Yervoy for the first-line treatment of advanced NSCLC.
We note that Opdivo is currently approved in many regions, including the United States, the EU and Japan, for several cancer indications. The company continues to evaluate Opdivo alone or in combination therapies with Yervoy and other anti-cancer agents. The Opdivo + Yervoy combination is already approved for the treatment of patients with unresectable or metastatic melanoma and intermediate or poor risk, previously untreated advanced renal cell carcinoma. The combination is also indicated for the treatment of adults and pediatric patients 12 years or older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) and for HCC.
Bristol-Myers currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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