PEMAZYRE (pemigatinib)
PEMAZYRE is indicated for the treatment of Cholangiocarcinoma; Myeloid/Lymphoid Neoplasms.
How PEMAZYRE Works
Pemigatinib is a small molecule kinase inhibitor that targets FGFR1, 2, and 3, and inhibits FGFR4 at significantly higher concentrations. The drug inhibits FGFR1-3 phosphorylation and signaling, which decreases cell viability in cancer cell lines with activating FGFR amplifications and fusions. By blocking constitutive FGFR signaling, pemigatinib disrupts the proliferation and survival of malignant cells.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2020-04-17
- Patent Cliff
- 2040
- Routes
- ORAL
- Dosage Forms
- TABLET
PEMAZYRE Approval History
What PEMAZYRE Treats
2 indicationsPEMAZYRE is approved for 2 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cholangiocarcinoma
- Myeloid/Lymphoid Neoplasms
PEMAZYRE Target & Pathway
ProTarget
PEMAZYRE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in PEMAZYRE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications PEMAZYRE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to PEMAZYRE
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
33 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06728410 | HCRN-GI23-621 | Ph 2 | recruiting | A Phase II Study of Pemigatinib Plus Durvalumab in Previously Treated Advanced Intrahepatic Cholangiocarcinoma Patients With FGFR-2 Fusion or Rearrangement |
| NCT07434843 PEMIGIST | 25-666 | Ph 2 | recruiting | PH 2 Pemigatinib in SDH-deficient GIST |
| NCT06906562 | OSU-23382 NCI-2025-03043 | Ph 2 | recruiting | A Phase II Nationwide, Fully Decentralized, Telemedicine Study of Pemigatinib in Adult Patients With Advanced or Metastatic Pancreatic Cancer With FGFR Genetic Alterations |
| NCT06302621 | 21-725 | Ph 1 | recruiting | Pemigatinib + Afatinib in Advanced Refractory Solid Tumors |
| NCT06439485 | 2024-0106 NCI-2024-04693 | Ph 1, Ph 2 | recruiting | Phase I/II Trial of Pemigatinib in Combination With Atezolizumab and Bevacizumab for Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion |
| NCT05267106 FIGHT-209 results posted | INCB 54828-209 2021-004740-24 | Ph 2 | terminated | Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Glioblastoma or Other Primary Central Nervous System Tumors Harboring Activating FGFR1-3 Alterations |
| NCT04659616 | STUDY00020009 NCI-2020-05267, STUDY00020009 | Ph 1 | recruiting | Pemigatinib After Chemotherapy for the Treatment of Newly Diagnosed Acute Myeloid Leukemia |
| NCT04463771 POD1UM-204 | INCMGA 0012-204 2022-502600-79-00, 2020-000496-20 | Ph 2 | active not recruiting | Safety and Efficacy of Retifanlimab (INCMGA00012) Alone or in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-based Chemotherapy. |
| NCT06300528 | HCI181541 | Ph 2 | recruiting | Pemigatinib in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphomas |
| NCT03498521 CUPISCO results posted | MX39795 2017-003040-20 | Ph 2 | completed | A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site |
| NCT03011372 results posted | INCB 54828-203 2016-002596-10 | Ph 2 | completed | A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203) |
| NCT04003610 results posted | INCB 54828-205 2019-000721-50 | Ph 2 | terminated | Pemigatinib + Pembrolizumab vs Pemigatinib Alone vs Standard of Care for Urothelial Carcinoma (FIGHT-205) |
| NCT03822117 results posted | INCB 54828-207 2018-004768-69 | Ph 2 | terminated | Efficacy and Safety of Pemigatinib in Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207) |
| NCT03914794 | J18158 IRB00194271 | Ph 2 | completed | A Study of Pemigatinib in Non-muscle Invasive Bladder Cancer Patients With Recurrent Low- or Intermediate-Risk Tumors |
| NCT06389799 PERELI | PERELI 2022-501993-21-00 | Ph 2 | recruiting | A Phase 2, Open Label Study of PEmigatinib and REtifanlimab in Advanced Dedifferentiated LIposarcoma (PERELI) |
| NCT03656536 FIGHT-302 | INCB 54828-302 2024-513513-12-00, 2018-002894-23 | Ph 3 | terminated | A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma |
| NCT02924376 results posted | INCB 54828-202 2016-002422-36 | Ph 2 | completed | Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202) |
| NCT02872714 results posted | INCB 54828-201 2016-001321-14 | Ph 2 | completed | A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Urothelial Carcinoma - (FIGHT-201) |
| NCT05253807 FIGHT-210 results posted | INCB 54828-210 2021-004934-12 | Ph 2 | completed | Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer With an FGFR Alteration |
| NCT06653777 AcSé PEMI | UC-GMP-2305 2024-512729-10-00 | Ph 2 | recruiting | Efficacy of Pemigatinib in Patients With Solid Tumors Characterized by an Alteration of the Gene FGFR in Tumor Cells |
| NCT04294277 PEGASUS results posted | EAU RF 2018-02 | Ph 2 | terminated | Safety and Efficacy of Pemigatinib in Patients With High-risk Urothelial Cancer After Radical Surgery |
| NCT05565794 | PEARLDIFER 2021-006232-50, IKF-t055 | Ph 2 | terminated | Pemigatinib After Curative Local Therapy in Advanced iCCA With FGFR2 Fusion/Rearrangements |
| NCT04949191 results posted | INCB 54828-801 | Ph 2 | terminated | The Purpose of the Study is to Continue to Provide Pemigatinib to Patients With Advanced Malignancies. |
| NCT06551896 | SYSKY-2024-546-01 | Ph 2 | not yet recruiting | Pemigatinib and Immune Checkpoint Inhibitor Treated FGFR1/2/3 Alteration Advanced Solid Tumor |
| NCT05159245 FINPROVE | FINPROVE | Ph 2 | recruiting | The Finnish National Study to Facilitate Patient Access to Targeted Anti-cancer Drugs |
| NCT04256980 | CIBI375A201 | Ph 2 | completed | Pemigatinib in Treating Patients With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Rearrangement |
| NCT04088188 results posted | ACCRU-ICRN-1701 NCI-2019-05811, ACCRU-ICRN-1701 | Ph 1 | terminated | Gemcitabine and Cisplatin With Ivosidenib or Pemigatinib for the Treatment of Unresectable or Metastatic Cholangiocarcinoma |
| NCT02925234 DRUP | M15DRU | Ph 2 | recruiting | The Drug Rediscovery Protocol (DRUP Trial) |
| NCT02393248 results posted | INCB 54828-101 | Ph 1, Ph 2 | terminated | Open-Label, Dose-Escalation Study of Pemigatinib in Subjects With Advanced Malignancies - (FIGHT-101) |
| NCT05651672 | TJ-0046 | Ph 2 | recruiting | Pemigatinib in the Advanced Gastrointestinal Cancer With FGFR 1-3 Alterations |
| NCT04003623 results posted | INCB 54828-MA-TA-208 | Ph 2 | terminated | Efficacy and Safety of Pemigatinib in Participants With Solid Tumors With FGFR Mutations or Translocations (FIGHT-208) |
| NCT04258527 | CIBI375A101 | Ph 1 | completed | Phase 1 Study of Pemigatinib in Patients With Advanced Malignancies With FGF/FGFR Alterations |
| NCT03235570 | INCB 54828-102 | Ph 1 | completed | A Safety and Tolerability Study of Pemigatinib in Japanese Subjects With Advanced Malignancies - (FIGHT-102) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PEMAZYRE FDA Label Details
Indications & Usage
FDA Label (PDF)PEMAZYRE is indicated for the treatment of Cholangiocarcinoma; Myeloid/Lymphoid Neoplasms.
PEMAZYRE Patents & Exclusivity
Patents (5 active)
Exclusivity
Pro Intelligence Preview
Deep insights for PEMAZYRE
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2040
- • 90 active patents
Trial Analysis
- • 34 total trials
- • Stage: Stable
Competitive Landscape
- • 1 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment