Tasigna gets agency nod for resistant Ph+ CML

October 31, 2007

Nilotinib capsules approved for Philadelphia chromosome-positive chronic myelogenous leukemia (CML).

Exerting its effect by targeting the Bcr-Abl protein, which is produced only by cells containing the abnormal Philadelphia (Ph) chromosome, nilotinib capsules (Tasigna, Novartis) have been granted an accelerated approval for the treatment of Ph+ chronic myelogenous leukemia (CML) in adult patients resistant or intolerant to prior therapy that included imatinib (Gleevec, Novartis). During clinical trials, nilotinib produced responses in 40% of Ph+ CML patients who were resistant or intolerant to prior therapy. According to Novartis, the new drug will be available within days of its approval.

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