ARIAD Pharmaceuticals Inc's NDA for ponatinib accepted by FDA for accelerated review for CML and Ph+ ALL leukemia.
M2 PHARMA-October 25, 2012-ARIAD Pharmaceuticals Inc's NDA for ponatinib accepted by FDA for accelerated review for CML and Ph+ ALL leukemia(C)2012 M2 COMMUNICATIONS
Oncology company ARIAD Pharmaceuticals Inc (NasdaqGS:ARIA) said on Wednesday that its New Drug Application (NDA) for ponatinib has been accepted for accelerated review for resistant or intolerant chronic myeloid leukemia (CML) or Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL).
The US Food and Drug Administration (FDA) has accepted the company's ponatinib for priority review and has established an action date of 27 March 2013 under the Prescription Drug User Fee Act (PDUFA).
According to the company, ponatinib is an investigational BCR-ABL inhibitor that 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 and Philadelphia-chromosome positive acute lymphoblastic leukemia.
CML is reportedly characterised by an excessive and unregulated production of white blood cells by the bone marrow due to a genetic abnormality that produces the BCR-ABL protein. Ph+ ALL is a subtype of acute lymphoblastic leukemia that carries the Ph+ chromosome that produces BCR-ABL.
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|Date:||Oct 25, 2012|
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