WASHINGTON (dpa-AFX) - Incyte Corp. (INCY) said that the U.S. Food and Drug Administration has approved Pemazyre (pemigatinib), a selective fibroblast growth factor receptor or FGFR inhibitor, for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms or MLNs with FGFR1 rearrangement. MLNs with FGFR1 rearrangement are extremely rare and aggressive blood cancers.
The approval marks the second indication for Pemazyre, which received accelerated FDA approval in 2020 for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement.
The company noted that Pemazyre is the only FGFR inhibitor with multiple indications.
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