Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration granted approval to pemigatinib for the treatment of adult patients with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement.

This is written in the approval document as:

PEMAZYRE is a kinase inhibitor indicated for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement.

Citation

Incyte Corporation. Pemazyre (pemigatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213736s002lbl.pdf. Revised August 2022. Accessed October 30, 2024.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	FGFR1 rearrangements	Myeloid/Lymphoid Neoplasms	Pemigatinib