NDA Submitted for Ponatinib for Chronic Myeloid Leukemia and Philadelphia-positive Acute Lymphoblastic Leukemia
Ariad Pharmaceuticals announced the submission of a New Drug Application (NDA) for ponatinib to the FDA, seeking marketing approval in patients with resistant or intolerant chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Ariad is seeking accelerated approval for ponatinib by the FDA and has requested a priority review of the application.
Results from the ongoing Phase 2 PACE trial of ponatinib showed that 54% of chronic-phase CML patients who were resistant or intolerant to tyrosine kinase inhibitor therapy in the trial, including 70% of patients who have a T315I mutation, achieved a major cytogenetic response (MCyR) – the primary endpoint of the PACE trial. Thirty percent of these same patients achieved a major molecular response (MMR). MMR is the primary endpoint of Ariad's Phase 3 EPIC trial comparing ponatinib to imatinib (Gleevec; Novartis) that is now underway in newly diagnosed chronic-phase CML patients.
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.