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Bristol-Myers Opdivo’s Regulatory Application Validated in EU

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Bristol-Myers Squibb Company BMY announced that its type II variation application for Opdivo has been validated by the European Medicines Agency (EMA). The company is looking to expand Opdivo’s label to include the treatment of locally advanced unresectable or metastatic urothelial carcinoma (mUC) in adults after a failure of prior platinum-containing therapy. The validation marks the initiation of the EMA’s centralized review process.

The application primarily included data from an open-label, single-arm phase II study, CheckMate -275. The company plans to present data from the study at the European Society for Medical Oncology Congress.

We are encouraged by the validation of the regulatory application for Opdivo in the EU. Per the company’s press release, bladder cancer is the fifth-most commonly diagnosed cancer in Europe, accounting for an estimated 151,000 new cases per year and resulting in 52,000 deaths annually. UC urothelial carcinoma is the most common type of bladder cancer, which accounts for roughly 90% of the cases.

Meanwhile, the company is also working on expanding the drug’s label. Opdivo is currently under priority review in the U.S. for the treatment of patients with previously treated recurrent or metastatic squamous cell carcinoma of the head and neck. A response from the FDA is expected by Nov 11, 2016. The product is also under review in the EU for the same indication.

Note that Opdivo has recorded worldwide sales of $1.5 billion in the first half of 2016. A label expansion in additional indications would give the product access to a higher patient population and increase the commercial potential of the drug significantly.

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Zacks Rank & Key Picks

Bristol-Myers currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in health care sector include ANI Pharmaceuticals, Inc. ANIP, Cambrex Corporation CBM and Abbott Laboratories ABT. While both ANI Pharmaceuticals and Cambrex sport a Zacks Rank #1 (Strong Buy), Abbott carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

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