Bristol-Myers Squibb Company (BMY) and partner Otsuka America Pharmaceutical, Inc. recently announced that the label of their leukemia drug Sprycel (dasatinib) has been updated by the US Food and Drug Administration (:FDA).
Following the FDA move, the US label of the drug includes three-year safety and efficacy data in patients suffering from newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (:CML) in chronic phase (CP). The US label of the drug also includes five-year data on CP Ph+ CML patients who are resistant or intolerant to Novartis’ (NVS) Glivec.
The three-year data was added to Sprycel’s label on the basis of encouraging follow-up data from an open-label, randomized, international phase III study (DASISION: n=519). The study evaluated Sprycel’s (100 mg, once daily) efficacy compared to Glivec as a first-line therapy in adults suffering from Ph+ CP-CML.
Sprycel’s US label update for CP Ph+ CML patients resistant or intolerant to Glivec includes data up to six years following the enrollment of the last patient in the phase III dose optimization CA180-034 study.
Sprycel is already available in multiple countries for treating adults in all phases (chronic, accelerated, or myeloid or lymphoid blast phase) of Ph+ CML either resistant or intolerant to prior treatments including Glivec. Moreover, the drug is also approved as a first-line therapy for treating adults suffering from Ph+ CML in the chronic phase. The drug has also been cleared for treating adults suffering from Ph+ acute lymphoblastic leukemia who are resistant or intolerable to prior medication.
Sprycel is one of the key drugs in Bristol-Myers’ product portfolio. The drug performed impressively in the first quarter of 2013 with sales climbing 24% to $287 million. We believe that the addition of long-term data to the US label of the drug further enhances its credibility.
Bristol-Myers currently carries a Zacks Rank #3 (Hold). Companies such as Santarus, Inc. (SNTS) and Salix Pharmaceuticals (SLXP) currently look more attractive with a Zacks Rank #1 (Strong Buy).
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