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Bristol-Myers' Opdivo-Yervoy sBLA for NSCLC Accepted by FDA

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Bristol-Myers Squibb Company (BMY - Free Report) announced that the FDA accepted the supplemental biologics license application (sBLA) for anti-PD-1 antibody Opdivo (nivolumab) in combination with Yervoy (ipilimumab) 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 FDA granted a priority review designation to the same and set an action date of May 15, 2020.

The sBLA was based on data from Part 1 of the phase III CheckMate-227 study, evaluating Opdivo plus Yervoy versus chemotherapy in patients with previously untreated NSCLC. In the study, the dual immunotherapy combination demonstrated significant improvement in overall survival rates compared to chemotherapy alone.

Shares of Bristol-Myers have surged 34.2% in the past year, outperforming the industry’s growth of 14.8%.

We note that Opdivo is currently approved in several countries, 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 and Yervoy combination is approved for the treatment of patients with unresectable or metastatic melanoma and intermediate or poor risk, previously untreated advanced renal cell carcinoma (RCC). The combination is also approved for the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC), which has progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan.

Opdivo generated sales of $5.4 billion in the first nine months of 2019, reflecting an increase of 10% year over year.

Label expansion of Opdivo into additional indications would lend the product access to a higher patient population and increase its commercial potential significantly.

However, the drug is facing competitive challenges in the United States from Merck’s (MRK - Free Report) PD-L1 inhibitor, Keytruda,


Zacks Rank & Other Stocks to Consider

Bristol-Myers currently carries a Zacks Rank #2 (Buy). 

A few better-ranked stocks from the healthcare space are Pfizer, Inc. (PFE - Free Report) and Eli Lilly & Co. (LLY - Free Report) . While Pfizer sports a Zacks Rank #1 (Strong Buy), Lilly carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.

Pfizer’s earnings per share estimates have moved up from $2.93 to $2.94 for 2019 and from $2.58 to $2.59 for 2020 in the past 60 days. The company delivered a positive earnings surprise of 8.73%, on average, in the last four quarters.

Lilly’s earnings per share estimates have increased from $5.79 to $5.80 for 2019 and from $6.56 to $6.77 for 2020 in the past 60 days. The company posted a positive earnings surprise in one of the last four quarters, with an average beat of 1.20%.

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