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These highlights do not include all the information needed to use PEMAZYRE safely and effectively. See full prescribing information for PEMAZYRE. PEMAZYRE® (pemigatinib) tablets, for oral use Initial U.S. Approval: 2020
Medication labelWhy this: Advisory · dailymed-prescription
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 [see Dosage and Administration (2.1)]. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). PEMAZYRE is indicated for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with fibroblast growth factor receptor 1 (FGFR1) rearrangement.
- generic_name
- pemigatinib
- product_names
- pemigatinib
- ndc
- 50881-026, 50881-026-01, 50881-027, 50881-027-01, 50881-028, 50881-028-01
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en