FDA approves ponatinib with chemotherapy for newly diagnosed Ph+ ALL, making Iclusig the first targeted therapy.
The FDA granted accelerated approval to ponatinib, with chemotherapy, for the treatment of adults with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). The approval is based on data from the phase 3 PhALLCON trial, which assessed the efficacy and safety of ponatinib in combination with chemotherapy in 245 patients with newly diagnosed Ph+ ALL. This makes Iclusig the first and only targeted therapy for these patients in the U.S.
March 19, 2024
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