Posted by Michael Wonder on 21 Dec 2020
U.S. FDA approves supplemental new drug application for Takeda’s Iclusig (ponatinib) for adult patients with resistant or intolerant chronic phase CML
19 December 2020 - Approval based on data from the Phase 2 OPTIC trial, which evaluated response-based Iclusig dosing regimens in CP-CML.
Takeda today announced that the U.S. FDA has approved the supplemental new drug application for Iclusig (ponatinib) for adult patients with chronic phase chronic myeloid leukaemia with resistance or intolerance to at least two prior kinase inhibitors.
