Bristol-Myers Squibb Company BMY announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion, recommending the approval for its immuno-oncology drug Opdivo for yet another indication. The company is looking to get Opdivo approved for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based combination chemotherapy in Europe.
The CHMP’s recommendation will now be reviewed by the European Commission (EC).
The positive CHMP opinion was based on favorable results from the phase III study ATTRACTION wherein Opdivo demonstrated superior overall survival (OS) versus chemotherapy for the given indication. In the study, treatment with Opdivo led to a statistically significant and clinically meaningful improvement in OS compared to chemotherapy as well as a favorable safety profile.
Per the press release, approximately 53,000 new cases of esophageal cancer, a type of gastrointestinal cancer, are diagnosed in Europe each year. Hence a possible nod in Europe for Opdivo to address the given indication will drive sales higher.
Shares of Bristol-Myers have decreased 4.6% so far this year against the industry’s increase of 0.3%.
We note that in June 2020, the FDA approved Opdivo for the treatment of patients with unresectable advanced, recurrent or metastatic ESCC after prior fluoropyrimidine- and platinum-based chemotherapy. Per the company, Opdivo is the first approved immunotherapy in this setting, regardless of the tumor PD-L1 expression level.
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 in various label expansion studies.
Approval of additional indications should boost Opdivo’s sales, which were not impressive during the first six months of 2020. Notably, the drug faces stiff competition from Merck’s MRK Keytruda, Roche’s RHHBY Tecentriq and AstraZeneca’s AZN Imfinzi, which are also approved for several cancer indications.
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.
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