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Bristol-Myers' Opdivo Label Expansion Under U.S., EU Review

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Bristol-Myers Squibb Company BMY received encouraging news with the FDA accepting and the European Medicines Agency (EMA) validating the company’s marketing applications for label expansion of its immuno-oncology drug Opdivo. The company is looking to get Opdivo approved for the treatment of patients with previously treated recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).

The company’s supplemental biologics license application for Opdivo has been accepted for priority review by the FDA. With the FDA granting priority review status, a response should be out by Nov 11, 2016. We remind investors that Opdivo was granted Breakthrough Therapy status in the U.S. for SCCHN in Apr 2016.

The EMA has validated a type II variation application for the same patient population. The validation marks the initiation of the EMA’s centralized review process.

We are encouraged by the simultaneous acceptance of Opdivo for review in the U.S. and EU. Data from the CheckMate -141 study has demonstrated that Opdivo is the first and only PD-1 inhibitor to show an overall survival benefit in a phase III study in these patients.

Per the company’s press release, head and neck cancer is the seventh most common cancer worldwide, accounting for an estimated 400,000 to 600,000 new cases per year resulting in 223,000 to 300,000 deaths annually. SCCHN accounts for approximately 90% of all head and neck cancers and is usually associated with a particularly poor prognosis and very low survival rates.

We note that Opdivo recorded worldwide revenues of $942 million in 2015. Label expansion into additional indications would give Opdivo access to an expanded patient population and increase the commercial potential of the drug.

Meanwhile, the company is working on expanding the drug’s label further. Opdivo is being evaluated for the treatment of various tumor types, alone or in combination with other approved cancer products such as Yervoy (Bristol-Myers’ other immuno-oncology drug).

Bristol-Myers is a Zacks Rank #1 (Strong Buy) stock. Other equally ranked stocks in the health care sector include Innoviva, Inc. INVA, Fibrocell Science, Inc. FCSC and Nektar Therapeutics (NKTR - Free Report) .

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