The U.S. Food and Drug Administration (FDA) has granted accelerated indication extension approval to Japan’s Takeda Pharmaceutical Company (TYO: 4502) for its tyrosine kinase inhibitor (TKI) Iclusig (ponatinib) in combination with chemotherapy for the treatment of newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). This follows the drug’s previous approvals for T315I-positive Ph+ ALL, Ph+ ALL patients with no kinase inhibitor alternatives, and various chronic myeloid leukemia (CML) indications.
The FDA’s conditional approval is based on promising early data from a late-stage clinical trial, which successfully met its primary endpoint of achieving a minimal residual disease (MRD)-negative complete remission (CR) rate after three cycles of treatment. Takeda reported that the combination therapy demonstrated over a two-fold improvement in this outcome compared to the standard treatment of TKI imatinib (Novartis’s Glivec) plus chemotherapy.
Safety profiles between the Iclusig and imatinib treatment arms were found to be comparable, indicating a favorable risk-benefit profile for the new indication.- Flcube.com
