FDA Approves Ponatinib for Upfront Ph+ ALL

The approval makes the third-generation tyrosine kinase inhibitor the first targeted treatment approved for upfront use in adults with Ph+ ALL, Takeda said in aas monotherapy for Ph+ ALL when no other kinase inhibitors are indicated or for T315I-positive Ph+ ALL, as well as for

At the end of induction, 12% of patients in the imatinib arm vs 30% in the ponatinib group were in complete remission with no minimal residual disease. Event-free survival data are not yet mature. Ponatinib carries a black box warning of arterial occlusive events, venous thromboembolic events, heart failure, and hepatotoxicity., fatigue, nausea, oral mucositis, hypertension, pancreatitis/elevated lipase, peripheral neuropathy, hemorrhage, febrile neutropenia, fluid retention and edema, vomiting, paresthesia, and cardiac arrhythmias.

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