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Bristol-Myers Leukemia Drug Sprycel's U.S. Label Updated

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Bristol-Myers Squibb Company BMY announced that the FDA has approved an update to the Sprycel label. The Sprycel label now includes five-year efficacy and safety data in adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP) and seven-year data in CP Ph+ CML patients who are resistant or intolerant to prior therapy, including Novatis’ NVS Gleevec.

The additional data now included in the Sprycel label will provide insight into the drug's long-term efficacy and safety profile in both treatment-naive and treatment-experienced patients who are resistant or intolerant to prior therapy.

Bristol-Myers has an agreement with Otsuka America Pharmaceutical, Inc. for Sprycel. Apart from CP Ph+ CML, Sprycel is approved for Ph+ acute lymphoblastic leukemia with resistance or intolerance to prior therapy. The product generated $780 million in the first half of 2015, accounting for almost 10% of Bristol-Myers’ total revenues.

We note that Bristol-Myers was in the news recently when the FDA extended the review period for the supplemental Biologics License Application for Opdivo for the treatment of patients with previously untreated advanced melanoma. The FDA is now expected to render a decision by Nov 27, 2015 (read more: Bristol-Myers’ Cancer Drug Opdivo FDA Action Date Delayed)

Bristol-Myers carries a Zack Rank #3 (Hold). Some better ranked stocks in the health care sector are Valeant Pharmaceuticals International, Inc. VRX and Infinity Pharmaceuticals, Inc. INFI. While Valeant carries a Zacks Rank #1 (Strong Buy), Infinity Pharma holds a Zacks Rank #2 (Buy).

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