Pemazyre

(Pemigatinib)

ApprovedSmall molecule

Pemazyre is a small molecule that works as a FGFR1/2/3 Inhibitor.[2] It is being used across 21 indications, with its most advanced program in Approved.[1]

Pemazyre is one of 533 small molecule programs targeting Lymphoma. It is currently in Approved.

Indications

Total Trials

Active Trials

532

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

LymphomaActive, not recruiting

Urogenital NeoplasmApproved

Intestinal CancerActive, not recruiting

Dedifferentiated LiposarcomaActive, not recruiting

Lymphoid NeoplasmActive, not recruiting

Intrahepatic CholangiocarcinomaActive, not recruiting

Biliary Tract CancerActive, not recruiting

Non-Small Cell Lung CancerActive, not recruiting

Breast CancerApproved

Colorectal CancerActive, not recruiting

LymphomaPhase 2

Active, not recruiting

Urogenital NeoplasmApproved

Approved

Intestinal CancerPhase 2

Active, not recruiting

Dedifferentiated LiposarcomaPhase 2

Active, not recruiting

Lymphoid NeoplasmPhase 2

Active, not recruiting

Intrahepatic CholangiocarcinomaPhase 2

Active, not recruiting

Biliary Tract CancerApproved

Active, not recruiting

Non-Small Cell Lung CancerPhase 2

Active, not recruiting

Breast CancerApproved

Approved

Colorectal CancerPhase 2

Active, not recruiting

Showing 10 of 21 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Pemazyre

Incyte

Approved

44 2

Trodelvy

Gilead

Preclinical

37 3

Zolymbus

AbbVie

Preclinical

1 4

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 5

Recentin

NNational Cancer Institute (NCI)

Preclinical

2 6

Spravato

WWim Janssens

Preclinical

2 7

Acupan

YYonsei University

Preclinical

1 8

Avastin

Roche

Preclinical

4 9

Nubain

AAultman Health Foundation

Preclinical

1 10

Feraheme

AAzurity Pharmaceuticals

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Cancer

NCT05159245

Phase 2Recruiting

Intestinal Cancer

NCT05651672

Phase 2Not yet recruiting

Immune Checkpoint Inhibitor

NCT06551896

Phase 1Recruiting

Acute Myeloid Leukemia

NCT04659616

Q1 2027

Phase 2Active, not recruiting

Refractory B-Cell Non-Hodgkin Lymphoma

NCT06300528

Q3 2027

Phase 2Recruiting

Intrahepatic Cholangiocarcinoma

NCT06728410

Clinical

Trials by Indication[1]

Cholangiocarcinoma5 trials

Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202)

Completed· Incyte logo

Incyte·Phase 2·NCT02924376·147 enrolled

A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma

Terminated· Incyte logo

Incyte·Phase 3·NCT03656536·167 enrolled

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

Recruiting·MM.D. Anderson Cancer Center·Phase 1/2·NCT06439485·25 enrolled

Show 2 more trials

Gemcitabine and Cisplatin With Ivosidenib or Pemigatinib for the Treatment of Unresectable or Metastatic Cholangiocarcinoma

Terminated·—·Phase 1·NCT04088188·8 enrolled

Pemigatinib in Treating Patients With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Rearrangement

Completed· Innovent Biologics (Suzhou) Co. Ltd. logo

Innovent Biologics (Suzhou) Co. Ltd.·Phase 2·NCT04256980·34 enrolled

Non-Small Cell Lung Cancer4 trials

Sintilimab With Pemigatinib in Patients With PD-L1-positive and FGFR Mutated Advanced Non-small Cell Lung Cancer

Recruiting·TThe Fourth Affiliated Hospital of Zhejiang University School of Medicine·Phase 2·NCT05004974·20 enrolled

A Single-Arm Phase II Clinical Study of Pemigatinib in the Treatment of Advanced Non-Small Cell Lung Cancer Patients With FGFR Alterations Who Have Failed Standard Therapy

Unknown status·TThe First Affiliated Hospital of Xiamen University·Phase 2·NCT05287386·20 enrolled

A Single-Arm Clinical Study of Pemigatinib in the Treatment of Advanced Non-Small Cell Lung Cancer Patients

Unknown status·TThe First Affiliated Hospital of Soochow University·N/A·NCT05210946·20 enrolled

Show 1 more trial

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

Completed· Incyte logo

Incyte·Phase 2·NCT05253807·8 enrolled

Advanced Malignancies4 trials

A Safety and Tolerability Study of Pemigatinib in Japanese Subjects With Advanced Malignancies - (FIGHT-102)

Completed· Incyte logo

Incyte·Phase 1·NCT03235570·44 enrolled

The Purpose of the Study is to Continue to Provide Pemigatinib to Patients With Advanced Malignancies.

Terminated· Incyte logo

Incyte·Phase 2·NCT04949191·10 enrolled

Open-Label, Dose-Escalation Study of Pemigatinib in Subjects With Advanced Malignancies - (FIGHT-101)

Terminated· Incyte logo

Incyte·Phase 1/2·NCT02393248·201 enrolled

Show 1 more trial

Phase 1 Study of Pemigatinib in Patients With Advanced Malignancies With FGF/FGFR Alterations

Completed· Innovent Biologics (Suzhou) Co. Ltd. logo

Innovent Biologics (Suzhou) Co. Ltd.·Phase 1·NCT04258527·12 enrolled

Colorectal Cancer2 trials

Pemigatinib for the Treatment of Metastatic or Unresectable Colorectal Cancer Harboring FGFR Alterations

Unknown status·—·Phase 2·NCT04096417·14 enrolled

A Single-Arm Phase II Exploratory Clinical Study of Pemigatinib in the Treatment of Advanced Gastric and Colorectal Cancer Patients With FGFR Alterations Who Have Failed Standard Therapy

Unknown status·UUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology·Phase 2·NCT05202236·20 enrolled

Urothelial Carcinoma2 trials

A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Urothelial Carcinoma - (FIGHT-201)

Completed· Incyte logo

Incyte·Phase 2·NCT02872714·263 enrolled

Pemigatinib + Pembrolizumab vs Pemigatinib Alone vs Standard of Care for Urothelial Carcinoma (FIGHT-205)

Terminated· Incyte logo

Incyte·Phase 2·NCT04003610·7 enrolled

25 more indications

Pancreatic Cancer2 trials

Expanded Access of Pemigatinib to Treat a Single Patient With Metastatic Pancreatic Cancer

No longer available· Incyte logo

Incyte··NCT03906357

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

Recruiting·SSameek Roychowdhury·Phase 2·NCT06906562·40 enrolled

Intrahepatic Cholangiocarcinoma2 trials

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

Recruiting·MMehmet Akce·Phase 2·NCT06728410·38 enrolled

Pemigatinib Combined With PD-1 Inhibitor in Unresectable or Metastatic Intrahepatic Cholangiocarcinoma

Unknown status·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·Phase 2·NCT05913661·30 enrolled

Advanced Refractory Solid Tumors1 trial

Pemigatinib + Afatinib in Advanced Refractory Solid Tumors

Recruiting·MMassachusetts General Hospital·Phase 1·NCT06302621·70 enrolled

Safety and Efficacy1 trial

Safety and Efficacy of Pemigatinib in Patients With High-risk Urothelial Cancer After Radical Surgery

Terminated·EEuropean Association of Urology Research Foundation·Phase 2·NCT04294277·2 enrolled

Solid Tumors1 trial

Pemigatinib for FGF/FGFR Alterations Advanced Pan Solid Tumors

Unknown status·TTianjin Medical University Second Hospital·Phase 2·NCT06022289·20 enrolled

Immunotherapy1 trial

The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy

Unknown status·FFondazione per la Medicina Personalizzata·Phase 2·NCT04591431·400 enrolled

Intestinal Cancer1 trial

Pemigatinib in the Advanced Gastrointestinal Cancer With FGFR 1-3 Alterations

Recruiting·TTianjin Medical University Cancer Institute and Hospital·Phase 2·NCT05651672·100 enrolled

Trial1 trial

The Drug Rediscovery Protocol (DRUP Trial)

Recruiting·TThe Netherlands Cancer Institute·Phase 2·NCT02925234·1,550 enrolled

Bladder Cancer1 trial

A Study of Pemigatinib in Non-muscle Invasive Bladder Cancer Patients With Recurrent Low- or Intermediate-Risk Tumors

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT03914794·30 enrolled

Patients With Solid Tumors1 trial

Efficacy of Pemigatinib in Patients With Solid Tumors Characterized by an Alteration of the Gene FGFR in Tumor Cells

Recruiting·UUNICANCER·Phase 2·NCT06653777·40 enrolled

Local Therapy1 trial

Pemigatinib After Curative Local Therapy in Advanced iCCA With FGFR2 Fusion/Rearrangements

Terminated·IInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest·Phase 2·NCT05565794·2 enrolled

Glioblastoma1 trial

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

Terminated· Incyte logo

Incyte·Phase 2·NCT05267106·83 enrolled

Cancer of Unknown Primary Site1 trial

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

Completed· Roche logo

Roche·Phase 2·NCT03498521·529 enrolled

Endometrial Cancer1 trial

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.

Active, not recruiting· Incyte logo

Incyte·Phase 2·NCT04463771·206 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Pemigatinib in Participants With Solid Tumors With FGFR Mutations or Translocations (FIGHT-208)

Terminated· Incyte logo

Incyte·Phase 2·NCT04003623·1 enrolled

Lymphoid Neoplasm1 trial

A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203)

Completed· Incyte logo

Incyte·Phase 2·NCT03011372·47 enrolled

Cancer1 trial

The Finnish National Study to Facilitate Patient Access to Targeted Anti-cancer Drugs

Recruiting·HHelsinki University Central Hospital·Phase 2·NCT05159245·250 enrolled

Immune Checkpoint Inhibitor1 trial

Pemigatinib and Immune Checkpoint Inhibitor Treated FGFR1/2/3 Alteration Advanced Solid Tumor

Not yet recruiting·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·Phase 2·NCT06551896·30 enrolled

Solid Tumor Malignancies1 trial

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)

Terminated· Incyte logo

Incyte·Phase 2·NCT03822117·111 enrolled

Gastric Cancer1 trial

A Single Arm, Phase II Exploratory Clinical Study of Pemitinib in Advanced Gastric Cancer With Previous Standard Therapy Failure the FGFR Variant

Unknown status·SSun Yat-sen University·Phase 2·NCT05997459·23 enrolled

Acute Myeloid Leukemia1 trial

Pemigatinib After Chemotherapy for the Treatment of Newly Diagnosed Acute Myeloid Leukemia

Recruiting·OOHSU Knight Cancer Institute·Phase 1·NCT04659616·32 enrolled

GIST1 trial

PH 2 Pemigatinib in SDH-deficient GIST

Not yet recruiting·—·Phase 2·NCT07434843·24 enrolled

Dedifferentiated Liposarcoma1 trial

A Phase 2, Open Label Study of PEmigatinib and REtifanlimab in Advanced Dedifferentiated LIposarcoma (PERELI)

Recruiting·LLund University Hospital·Phase 2·NCT06389799·33 enrolled

Squamous Carcinoma1 trial

Pemigatinib in Subjects With Adenosquamous Carcinoma of the Pancreas

Withdrawn·HHonorHealth Research Institute·Phase 2·NCT05216120

Refractory B-Cell Non-Hodgkin Lymphoma1 trial

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

Active, not recruiting·UUniversity of Utah·Phase 2·NCT06300528·1 enrolled

Regulatory

FDA Approval Timeline[4]

Apr 17, 2020

PEMAZYRE

NDA NDA213736

Sources

References

[1]
ClinicalTrials.gov — 44 trial records for Pemigatinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Pemigatinib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Pemigatinib. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA213736). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Pemazyre. U.S. Food & Drug Administration.
[6]
PubMed — 1 publication indexed for Pemigatinib. U.S. National Library of Medicine.
[7]
SEC EDGAR — Incyte company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: FGFR1/2/3 Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Incyte

Patent Landscape[5]

Patent Cliff

Apr 17, 2034

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10131667Apr 17, 2034

9611267Jan 30, 2035

11466004May 3, 2039

11628162Aug 30, 2040

12552792Oct 3, 2040

Key Publications[6]

Pemigatinib in FGFR2-Rearranged Cholangiocarcinoma: FIGHT-202 Updated

Lancet OncolAug 25, 2022DOI: 10.1016/S1470-2045(22)00455-2

Pemazyre

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q3 2027

Trials by Indication[1]

Cholangiocarcinoma5 trials

Non-Small Cell Lung Cancer4 trials

Advanced Malignancies4 trials

Colorectal Cancer2 trials

Urothelial Carcinoma2 trials

Pancreatic Cancer2 trials

Intrahepatic Cholangiocarcinoma2 trials

Advanced Refractory Solid Tumors1 trial

Safety and Efficacy1 trial

Solid Tumors1 trial

Immunotherapy1 trial

Intestinal Cancer1 trial

Trial1 trial

Bladder Cancer1 trial

Patients With Solid Tumors1 trial

Local Therapy1 trial

Glioblastoma1 trial

Cancer of Unknown Primary Site1 trial

Endometrial Cancer1 trial

Efficacy and Safety1 trial

Lymphoid Neoplasm1 trial

Cancer1 trial

Immune Checkpoint Inhibitor1 trial

Solid Tumor Malignancies1 trial

Gastric Cancer1 trial

Acute Myeloid Leukemia1 trial

GIST1 trial

Dedifferentiated Liposarcoma1 trial

Squamous Carcinoma1 trial

Refractory B-Cell Non-Hodgkin Lymphoma1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

Key Publications[6]

Related News