FDA approves pemigatinib, a selective fibroblast growth factor receptor inhibitor, for adults with relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 rearrangement.
According to Incyte, the final results showed an overall complete response rate of 79%. Among 18 patients with chronic phase involvement of the bone marrow with or without extramedullary disease, 78% achieved a complete response. In addition, 2 of 4 patients with blast phase in the marrow with or without extramedullary disease achieved a complete response, as did 1 of 3 patients with only extramedullary disease.
The high rate of complete responses in these patients"is clinically meaningful, especially in light of the lack of these specific responses with existing first-line treatments," principal investigator Srdan Verstovsek, MD, PhD, of the University of Texas MD Anderson Cancer Center, Houston, says in the release.
The study participants received pemigatinib 13.5 mg once daily in 21-day cycles, either on a continuous schedule or on an intermittent schedule with 14 days on, 7 days off, until disease progression or unacceptable toxicity, or until patients were eligible to receive allogeneic HSCT. The continuous dosing schedule is the approved recommended starting dosage for use in patients with MLNs with
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