Therapeutic Response Statement (Sensitivity)

This therapeutic response statement supports the relationship that FGFR1 rearrangements status confers therapeutic sensitivity to Pemigatinib in patients with Myeloid/Lymphoid Neoplasms.

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 statement is based on a regulatory approval from the Food and Drug Administration:

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.