Takeda : FDA Approves SNDA For Iclusig In Adult Patients With Newly Diagnosed Ph+ ALL

(RTTNews) - Japan's Takeda Pharmaceutical Co. Ltd. (TAK) said that the U.S. Food and Drug Administration approved the supplemental New Drug Application or sNDA for Iclusig (ponatinib) for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy.

The indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete remission at the end of induction. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

The accelerated approval application was granted Priority Review and evaluated under the Real-Time Oncology Review program, an FDA initiative designed to expedite the delivery of cancer medicines by allowing components of an application to be reviewed before submission of the complete application.

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