FDA Approval Insights: Pemigatinib in FGFR1-Rearranged Myeloid/Lymphoid Neoplasms


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Dr Verstovsek discusses the FDA approval of pemigatinib in myeloid/lymphoid neoplasms with FGFR1 rearrangements, the transformative effects of pemigatinib, and the importance of identifying chromosomal abnormalities in patients with this aggressive disease.

Welcome to OncLive On Air®! I’m your host today, Ashling Wahner.

OncLive On Air® is a podcast from OncLive®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive® covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, we had the pleasure of speaking with Srdan Verstovsek, MD, PhD, the United Energy Resources, Inc, Professor of Medicine and a hematologist-oncologist in the Department of Leukemia, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center. Dr Verstovsek joined us to talk about pemigatinib (Pemazyre) in myeloid/lymphoid neoplasms with FGFR1 rearrangements.

On August 26, 2022, the FDA approved pemigatinib in patients with FGFR1-rearranged, relapsed/refractory myeloid neoplasms. The agency based its approval on findings from the phase 2 FIGHT-203 trial (NCT03011372), in which the agent elicited a complete cytogenic response rate of 79%. Additionally, 78% of patients with chronic phase in the marrow achieved a complete response with pemigatinib.

In our exclusive interview, Dr Verstovsek discussed the significance of this approval in this rare patient population. He also described the transformative effects of pemigatinib coupled with a manageable toxicity profile and emphasized the importance of identifying chromosomal abnormalities in patients when determining the optimal treatment for this aggressive disease.


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