FDA Approves Pemigatinib for Myeloid/Lymphoid Neoplasms with FGFR1 Rearrangement

By Cecilia Brown - Last Updated: October 13, 2022

The FDA has approved pemigatinib, a selective fibroblast growth factor receptor (FGFR) inhibitor, for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement.

The approval was based on data from the phase II FIGHT-203 study, a multicenter, open-label, single-arm trial that evaluated the safety and efficacy of pemigatinib in 28 patients with relapsed or refractory MLNs with FGFR1 rearrangement. Patients could have relapsed after allogeneic HSCT or after a disease-modifying therapy or were not a candidate for allogeneic HSCT or other disease-modifying therapies.

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