Pemigatinib

PEMAZYRE is a kinase inhibitor

Prescribing label

Selected manufacturer label information, organised into consistent sections by Sofidex. This source is written for healthcare professionals; ask your pharmacist to explain instructions that are unclear.

Drug facts

Used for: for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. ( 1, 2.1 ) This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1, 2.1 )
For the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement. ( 1, 2.1 ) 1.1 Cholangiocarcinoma PEMAZYRE is indicated
for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Myeloid/Lymphoid Neoplasms with FGFR1 Rearrangement PEMAZYRE is indicated

What it is used for

PEMAZYRE is a kinase inhibitor indicated: for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. ( 1, 2.1 ) This indication is approved under accelerated approval based on overall response rate and duration of response.

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1, 2.1 ) For the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement. ( 1, 2.1 ) 1.1 Cholangiocarcinoma PEMAZYRE is indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.

This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Myeloid/Lymphoid Neoplasms with FGFR1 Rearrangement PEMAZYRE is indicated for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with fibroblast growth factor receptor 1 (FGFR1) rearrangement.

Cite this page

NLM: sofidex [Internet]. Daloreum; c2026. Pemigatinib; [reviewed 2026 Aug 3; cited 2026 Nov 10]. Available from: https://sofidex.com/patients/medicines/pemigatinib
APA 7th: sofidex. (2026, August 3). Pemigatinib. Daloreum. Retrieved November 10, 2026, from https://sofidex.com/patients/medicines/pemigatinib
AMA 11th: Pemigatinib. sofidex. Reviewed August 3, 2026. Accessed November 10, 2026. https://sofidex.com/patients/medicines/pemigatinib

The cited date is today’s, because a citation records when you read the page. The reviewed date is when a clinician last checked it.