NDA Accepted, Priority Review Granted for Ponatinib for CML and Ph+ ALL
ARIAD Pharmaceuticals announced that the FDA has accepted for filing the New Drug Application (NDA) of ponatinib for patients with resistant or intolerant chronic myeloid leukemia (CML) or Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL); the FDA also has granted ARIAD's request for Priority Review.
The FDA has established an action date of March 27, 2013 under the Prescription Drug User Fee Act (PDUFA).
Ponatinib is an investigational BCR-ABL inhibitor that also selectively inhibits certain other tyrosine kinases in preclinical studies, including FLT3, RET, KIT, and the members of the FGFR and PDGFR families of kinases. The primary target for ponatinib is BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Ponatinib targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment with existing tyrosine kinase inhibitors, including the T315I mutation for which no effective therapy currently exists.
For more information call (877) 621-2302 or visit www.ariad.com.