Pemigatinib
Fibroblast Growth Factor Receptor (Fgfr) Tyrosine Kinase Inhibitors
Sold as PEMAZYRE
- Drug class
- Fibroblast Growth Factor Receptor (Fgfr) Tyrosine Kinase Inhibitors
- Availability
- See label
- Routes
- Oral
- Markets covered
- 3
- Products on record
- 12
Overview
Pemigatinib is an active pharmaceutical ingredient in the Fibroblast Growth Factor Receptor (Fgfr) Tyrosine Kinase Inhibitors group (L01EN). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 8 | January 23, 2026 |
| CA Canada | Health Canada | 3 | March 22, 2025 |
| EU European Union | EMA | 1 | March 17, 2026 |
GBUnited Kingdom· MHRA
8 products
Uses
Pemazyre monotherapy is indicated for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.
How to take
CACanada· Health Canada
3 products
Uses
PEMAZYRE™ (pemigatinib) 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.
Clinical effectiveness of PEMAZYRE™ is based on overall response rate (ORR) and duration of response (DoR) from a single-arm Phase 2 trial in patients with specific FGFR2 rearrangements (see 14 CLINICAL TRIALS). Treatment with PEMAZYRE™ should be initiated following confirmation of a FGFR2 fusion or rearrangement using a validated test (see 14 CLINICAL TRIALS).
1 Pediatrics Pediatrics (18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use (see 7 WARNINGS AND PRECAUTIONS, Special Populations). 5%) were ≥ 65 years.
No overall differences in safety or effectiveness were observed between elderly and younger patients.
EUEuropean Union· EMA
1 product
Uses
Pemazyre monotherapy is indicated for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.
How to take
Drug interactions
Known interactions involving Pemigatinib. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PLGB423380010 · revised January 23, 2026
- [2]Health Canada (DPD) · 02519933 · revised March 22, 2025
- [3]European Medicines Agency · EMEA/H/C/005266 · revised March 17, 2026
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.