Incyte’s Pemazyre Snags FDA Nod for Aggressive Blood Cancers

The FDA has approved Incyte’s fibroblast growth factor receptor (FGFR) inhibitor, Pemazyre (pemigatinib), for treating adults suffering from relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangements — extremely rare, aggressive blood cancers.

The approval was supported by positive results from a phase 2 study single-arm study that evaluated Pemazyre in 28 patients with the extremely rare, aggressive blood cancers.

For patients suffering from chronic phase in the bone marrow, the complete response rate was 78 percent, while the complete cytogenetic response rate for all study patients was 79 percent, which means these patients’ bone marrow cells had less than 1 percent of a mutant chromosome associated with blood cancer.

The Wilmington, Del.-based company’s supplemental New Drug Application for Pemazyre was reviewed under an FDA Priority Review, which shortens the agency’s review time from 10 months to six months for promising new medicines.