Leukemia Drug Granted Accelerated Review

Ponatib receives FDA priority review

/ Author:  / Reviewed by: Joseph V. Madia, MD

(RxWiki News) The U.S. Food and Drug Administration has granted Ariad Pharmaceuticals, Inc. accelerated review of its drug ponatinib to treat patients who have chronic myeloid leukemia (CML) that doesn’t respond to current medications.

Priority Review, which shortens review time from 10 to 6 months, was also given to the drug as a possible treatment for Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL), the company has reported.

"Find out what drugs are in the pipeline to treat your cancer."

Accelerated review is given to investigational drugs that could significantly improve disease treatment, prevention or diagnosis.

The review of ponatinib will be complete by March 27, 2013.

Ponatinib targets and blocks an abnormal protein BCR-ABL that’s seen in CML and BCR-ABL.

The company’s Phase 2 PACE (Ponatinib Ph+ ALL and CML Evaluation) has shown promising results to date.
 

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Review Date: 
October 25, 2012
Last Updated:
November 8, 2012