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Drug

Pemigatinib

Approved · EMA
Late-stage development

Also known as Pemazyre.

RxNorm2359268ChEMBLCHEMBL4297522UNIIY6BX7BL23K
13
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Pemigatinib and Immune Checkpoint Inhibitor Treated FGFR1/2/3 Alteration Advanced Solid Tumor: a Single Arm, Multiple Center, Phase II Study (Pigeon Study)

Clinical trial2026-07-31Primary completion · ClinicalTrials.gov

A Multicenter, Phase 1, Open-Label Study of the FGFR Inhibitor Pemigatinib (INCB054828) Administered After Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With Adverse or Intermediate Risk Cytogenetics

Clinical trial2026-07-14Results expected Q4 2026 · ClinicalTrials.gov

A Phase II Study of Pemigatinib Plus Durvalumab (MEDI4736) in Previously Treated Advanced Intrahepatic Cholangiocarcinoma Patients With FGFR-2 Fusion or Rearrangement

Clinical trial2026-07-01Primary completion · ClinicalTrials.gov

An Umbrella Study of INCMGA00012 Alone and in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-Based Chemotherapy (POD1UM-204)

Clinical trial2026-05-29Completed · ClinicalTrials.gov

PEMIGIST: Phase 2 Study of Pemigatinib (INCB054828) in the Treatment of Patients With Advanced SDH-deficient Gastrointestinal Stromal Tumor (GIST)

Clinical trial2026-05-22Results expected Q4 2028 · ClinicalTrials.gov

A Phase Ia/Ib Study of the Combination of the FGFR Inhibitor Pemigatinib and the EGFR Inhibitor Afatinib in Advanced Refractory Solid Tumors

Clinical trial2026-05-15Results expected Q4 2027 · ClinicalTrials.gov

PERFORM: A Phase II Study of Pemigatinib in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphomas

Clinical trial2026-03-16Primary completion · ClinicalTrials.gov

A Phase II Nationwide, Fully Decentralized, Telemedicine Study of Pemigatinib in Adult Patients With Advanced or Metastatic Pancreatic Cancer With FGFR2 Gene Fusions or Other FGFR Genetic Alterations

Clinical trial2026-02-17Results expected Q4 2026 · ClinicalTrials.gov

Phase I/II Trial of Pemigatinib in Combination With Atezolizumab and Bevacizumab for Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion

Clinical trial2026-01-14Results expected Q1 2028 · ClinicalTrials.gov

A Phase II, Randomized, Active-Controlled, Multi-Center Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Guided by Genomic Profiling Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site Who Have Received Three Cycles of Platinum Doublet Chemotherapy

Clinical trial2025-11-19Results posted · ClinicalTrials.gov

A Phase 2, Open-Label, Monotherapy, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203)

Clinical trial2025-11-18Results posted · ClinicalTrials.gov

Approval: Pemazyre (EMA)

Regulatory2021-03-26EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Pemigatinib
Aliases & brands
Pemazyre
RxNorm CUI
2359268
ChEMBL ID
CHEMBL4297522
UNII
Y6BX7BL23K
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2021-03-26
Latest approval
2021-03-26
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2021-03-26Approval
Approval: Pemazyre (EMA)
Indication: 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… Show full indication

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.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

43 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
43
registered trials across all phases
LATEST COMPLETION 2026
13
Active studies
12
Recruiting
2
Late-stage (III+)
10
Completed
20
Discontinued
PHASE DISTRIBUTIONn = 43
Phase 15Phase 1 / 22Phase 234Phase 31Phase N / A1

Recent completions

Trials that read out recently, adding to the completed evidence base.

An Umbrella Study of INCMGA00012 Alone and in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-Based Chemotherapy (POD1UM-204)

CompletedPH IIIncyte Corporationn=2062026

Phase 2 Window of Opportunity Study of Pemigatinib in Non-muscle Invasive Bladder Cancer Patients With Recurrent Low- or Intermediate-Risk Tumors

CompletedPH IISidney Kimmel Comprehensive Cancer Center at Johns Hopkinsn=302025

A Phase II, Randomized, Active-Controlled, Multi-Center Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Guided by Genomic Profiling Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site Who Have Received Three Cycles of Platinum Doublet Chemotherapy

CompletedPH IIHoffmann-La Rochen=5292024

A Phase 2, Open-Label, Monotherapy, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203)

CompletedPH IIIncyte Corporationn=472024

A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Rearrangement Who Failed at Least One Previous Therapy

CompletedPH IIInnovent Biologics (Suzhou) Co. Ltd.n=342023

A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Advanced Non-Small Cell Lung Cancer With an FGFR Alteration Who Progressed on Previous Therapy (FIGHT 210)

CompletedPH IIIncyte Corporationn=82023
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.