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AUGUST 30, 2022

FDA Grants Pemazyre a New Indication for Myeloid/Lymphoid Neoplasms

By SPC News Staff

The FDA granted a new indication for pemigatinib (Pemazyre, Incyte) to treat adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with fibroblast growth factor receptor 1 (FGFR1) rearrangement.

Pemigatinib received accelerated FDA approval in 2020 for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion or other rearrangement.

Pemigatinib is a selective fibroblast growth factor receptor inhibitor. The