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Bristol Myers' (BMY) Opdivo Wins EC Nod for Esophageal Cancer

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Bristol Myers Squibb BMY announced that the European Commission (EC) has approved its blockbuster immuno-oncology drug, Opdivo (nivolumab), for another indication.

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

The approval was based on results from the phase III ATTRACTION-3 study, sponsored by Ono Pharmaceutical Co., Ltd. of Japan, which demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) in patients who received Opdivo as compared to those receiving chemotherapy. The safety profile for Opdivo was favorable compared with chemotherapy and consistent with previously reported studies of the drug in other solid tumors.

On a worldwide basis, esophageal cancer is the seventh most common cancer and the sixth most common cause of death from cancer.

We note that Opdivo is already approved in the United States and Japan, for the second-line treatment of patients with unresectable advanced, recurrent or metastatic ESCC. Approval in additional geographies increases the sales potential of the drug.

Opdivo is approved in several countries for various indications — unresectable or metastatic melanoma, metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, metastatic small cell lung cancer (SCLC) with progression after platinum-based chemotherapy, advanced renal cell carcinoma (RCC), adult patients with classical Hodgkin lymphoma (cHL), and recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN), among others. It is also approved for various indications in combination with Yervoy.

Shares of Bristol-Myers have decreased 1.5% so far this year, in-line with the industry’s decline. 

Approval of additional indications should boost Opdivo’s sales, which were not impressive in the year so far. Notably, the drug faces stiff competition from Mercks MRK Keytruda and Roches RHHBY Tecentriq, particularly for the NSCLC indication.

Bristol-Myers currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech space is Halozyme Therapeutics, Inc. HALO, which sports a Zacks Rank #1 (Strong Buy), presently. You can see the complete list of today’s Zacks #1 Rank stocks here.

Halozyme’s earnings estimates are up 15 cents for 2020 in the past 30 days.

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Roche Holding AG (RHHBY) : Free Stock Analysis Report
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