NDAORALTABLETPriority Review
Approved
Apr 2020
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
Priority Review
PEMAZYRE (pemigatinib) by Incyte is kinase inhibitors [moa]. Approved for kinase inhibitor [epc]. First approved in 2020.
Drug data last refreshed 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PEMAZYRE (pemigatinib) is an oral kinase inhibitor approved in April 2020 for treating cholangiocarcinoma and other solid tumors driven by FGFR2 or FGFR3 alterations. It selectively targets fibroblast growth factor receptor (FGFR) mutations to block aberrant kinase signaling in genetically defined patient populations.
$26MPart D
Peak14.0 years to LOEPEMAZYRE is in peak commercial phase with modest Part D penetration (1,380 claims in 2023), suggesting a specialized niche franchise with limited team expansion near-term.
Mechanism of Action
Kinase Inhibitors
Pharmacologic Class:
Kinase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Pemigatinib Plus PD-1 Inhibitor With or Without Chemotherapy in FGFR2 Fusion/Rearrangement-Positive Cholangiocarcinoma
Started Aug 2026
154 enrolled
Biliary Tract Cancer (BTC)
PH 2 Pemigatinib in SDH-deficient GIST
Started May 2026
24 enrolled
SDH Gene MutationGastrointestinal Stromal Tumor
A Phase II Study of Pemigatinib Plus Durvalumab in Previously Treated Advanced Intrahepatic Cholangiocarcinoma Patients With FGFR-2 Fusion or Rearrangement
Started Jan 2026
38 enrolled
Intrahepatic CholangiocarcinomaFGFR2 Gene RearrangementFGFR2 Gene Mutation
Pemigatinib in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphomas
Started Oct 2025
1 enrolled
Relapsed or Refractory B-cell Non-Hodgkin LymphomaMantle Cell LymphomaMarginal Zone Lymphoma
A Phase II Nationwide, Fully Decentralized, Telemedicine Study of Pemigatinib in Adult Patients With Advanced or Metastatic Pancreatic Cancer With FGFR Genetic Alterations
Started Aug 2025
40 enrolled
Advanced Pancreatic CarcinomaMetastatic Pancreatic CarcinomaStage II Pancreatic Cancer AJCC v8+2 more
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.