Incyte has received the Food and Drug Administration’s clearance for Pemazyre (pemigatinib), a selective fibroblast growth factor receptor inhibitor.
The medication is indicated for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 rearrangement.
“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, CEO of Incyte. “These are complex hematologic malignancies with a range of presentations, and this approval highlights Incyte’s continued leadership and commitment to advancing care for patients with rare blood cancers.”
MLNs with FGFR1 rearrangement are extremely rare and aggressive blood cancers that may impact less than 1 in 100,000 people in the United States, the company noted.
“In patients with relapsed or refractory MLNs with FGFR1 rearrangement treated with Pemazyre in FIGHT-203, the high rate of complete response and complete cytogenetic response in patients with chronic phase disease and the high rate of complete cytogenetic response in patients with blast phase disease is clinically meaningful, especially in light of the lack of these specific responses with existing first-line treatments,” said Srdan Verstovsek, professor, department of Leukemia, division of Cancer Medicine, The University of Texas MD Anderson Cancer Center and principal investigator for the FIGHT-203 study.
Pemazyre, a fibroblast growth factor receptor inhibitor, is the first targeted treatment approved for use in the United States for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 rearrangement.
Pemazyre also is indicated for the treatment of adults with relapsed or refractory previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or other rearrangement as detected by an FDA-approved test. This indication is approved under accelerated approval based on the overall response rate and duration of response. Continued approval may be contingent on verification and description of clinical benefit in a confirmatory trial(s).