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Bristol-Myers Gets FDA Nod for Label Expansion of Opdivo

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Bristol-Myers (BMY - Free Report) announced that the FDA has approved blockbuster immuno-oncology drug, Opdivo, for yet another indication.

The drug is now approved for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.

The approval was based on positive results from the phase III study, ATTRACTION, wherein Opdivo demonstrated superior overall survival (OS) versus taxane chemotherapy.

Per the company, Opdivo is the first approved immunotherapy in this setting, regardless of tumor PD-L1 expression level.

While this approval comes with a few warnings and precautions, approval in other indications will boost sales of the drug. Per the company, approximately 18,440 new cases of esophageal cancer, a type of gastrointestinal cancer, will be diagnosed in the United States and approximately 16,170 deaths will result from the disease this year.

We note that the drug 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.

Last month, the FDA approved the combination of Opdivo and Yervoy for the lucrative indication of first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC).

The approval not only opens an important treatment option for the affected patients but also presents an opportunity for Opdivo to gain market share.

Opdivo sales were not impressive in the first quarter. Notably, the drug faces stiff competition from Merck’s (MRK - Free Report) Keytruda and Roche’s (RHHBY - Free Report) Tecentriq. AstraZeneca’s (AZN - Free Report) Imfinzi is also approved for lung cancer.

Bristol-Myers’ shares have lost 4.8% so far this year against the industry’s growth of 1.3%.

The label expansion of Opdivo for additional indications should boost sales but gaining market share from Keytruda will be a daunting task.

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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