Regulatory approval

Published by the Food and Drug Administration. Approved

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

This is written in the approval document.

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.

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	FGFR1 rearrangements	Myeloid Neoplasm	Pemigatinib
FDA (2)	FGFR1 rearrangements	Lymphocytic Neoplasm	Pemigatinib

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2022-08-26	Food and Drug Administration	Indication received traditional approval.