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FDA approves new leukemia drug

Ariad's Iclusig approved three months' ahead of PDUFA target date

SILVER SPRING, Md. — The Food and Drug Administration has approved a new leukemia drug made by Ariad Pharmaceuticals, the agency said Friday.

The FDA announced the approval of Iclusig (ponatinib) to treat chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia, also known respectively as CML and Ph+ ALL.

The drug's approval is happening more than three months ahead of the FDA's originally intended decision date of March 27, 2013 because the agency reviewed the drug under its priority review program, which allows for an expedited six-month review for drugs that may provide safe and effective therapy when no satisfactory alternative therapy exists, or if the drug offers a significant improvement over existing products.


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