FDA has approved the selective fibroblast growth factor receptor (FGFR) inhibitor Pemazyre (pemigatinib) to treat adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement.
The drug, developed by Incyte (Nasdaq:INCY), first won approval for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma.
The latest indication, MLNs with FGFR1 rearrangement, covers an extremely rare and aggressive form of blood cancer.
A 2019 article in Frontiers in Oncology noted that there had been approximately 100 cases of the cancer reported to date.
“The approval of Pemazyre represents an important treatment advancement for people living with MLNs with FGFR1 rearrangement who currently have limited treatment options,” said Hervé Hoppenot, Incyte CEO, in a news release. “These are complex hematologic malignancies with a range of presentations, and this approval highlights Incyte’s continued…