Novartis’ Tasigna receives nod from FDA

SILVER SPRING, Md. The Food and Drug Administration has approved a drug as an early treatment for a rare form of blood cancer, the agency said Thursday.

The FDA approved Novartis’ Tasigna (nilotinib) for newly diagnosed Philadelphia chromosome positive chronic phase chronic myeloid leukemia, also called Ph+ CP-CML. The disease is a slowly progressing cancer of the blood and bone marrow resulting from a genetic abnormality. The agency originally approved Tasigna in 2007 for Ph+ CP-CML in adults whose disease had progressed or who could not tolerate other therapies, such as Gleevec (imatinib), also made by Novartis.

“It’s important for companies to continue developing oncology drugs for earlier stages of the disease once they have demonstrated clinical effectiveness in resistant forms of cancer,” FDA Center for Drug Evaluation and Research Office of Oncology Drug Products Richard Pazdur said. “This approach has the potential to increase the availability of an effective treatment to more patients.”