The Food and Drug Administration approved pemigatinib (Pemazyre, Incyte Corporation) for adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with fibroblast growth factor receptor 1 (FGFR1) rearrangement.
- Efficacy was established based on complete response (CR) rates per the response criteria relevant to the morphologic disease type.
- The recommended pemigatinib dose is 13.5 mg orally once daily on a continuous basis until disease progression or unacceptable toxicity.