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.

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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