Pemazyre

(Pemigatinib)

ApprovedSmall molecule

Pemazyre is a small molecule that works as a FGFR1/2/3 Inhibitor.[2] It is being used across 19 indications, with its most advanced program in Approved.[1]

Pemazyre is one of 431 small molecule programs targeting Urogenital Neoplasm. It is currently in Approved.

Indications

Total Trials

Active Trials

430

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Urogenital NeoplasmApproved

Intestinal CancerRecruiting

Dedifferentiated LiposarcomaRecruiting

Biliary Tract CancerActive, not recruiting

Non-Small Cell Lung CancerRecruiting

Breast CancerApproved

Pancreatic CancerRecruiting

Acute Myeloid LeukemiaRecruiting

Endometrial CancerActive, not recruiting

CancerRecruiting

Urogenital NeoplasmApproved

Approved

Intestinal CancerPhase 2

Recruiting

Dedifferentiated LiposarcomaPhase 2

Recruiting

Biliary Tract CancerApproved

Active, not recruiting

Non-Small Cell Lung CancerPhase 2

Recruiting

Breast CancerApproved

Approved

Pancreatic CancerPhase 2

Recruiting

Acute Myeloid LeukemiaPhase 1

Recruiting

Endometrial CancerPhase 2

Active, not recruiting

CancerPhase 2

Recruiting

Showing 10 of 19 indications

Competition

Competitive Landscape

706 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Pemazyre

Incyte

Approved

46 2

Adenocard

Astellas

Preclinical

2 3

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 4

Rilvegostomig

AstraZeneca

Preclinical

1 5

Vfend

PPrism Pharmaceuticals

Preclinical

—6

Recombinant Human Endostatin

PPeking University Third Hospital

Preclinical

1 7

Tianeptine

Pfizer

Preclinical

1 8

Diuretic

RReprieve Cardiovascular, Inc

Preclinical

1 9

Tc99m Sestamibi

MM.D. Anderson Cancer Center

Preclinical

2 10

Liposomal Irinotecan and Apatinib

SSecond Affiliated Hospital, School of Medicine, Zhejiang University

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

Q4 2027

Phase 2Recruiting

Trial

NCT02925234

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer4 trials

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

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

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

Show 1 more trial

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

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

Cholangiocarcinoma3 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

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

Intrahepatic Cholangiocarcinoma2 trials

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

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

Recruiting·MMehmet Akce·Phase 2·NCT06728410·38 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

28 more indications

Pancreatic Cancer2 trials

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

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

No longer available· Incyte logo

Incyte··NCT03906357

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

Unresectable Cholangiocarcinoma2 trials

A Phase 2, Single-Arm, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma With FGFR2 Fusion or Rearrangements After at Least 1 Prior Line of Systemic Therapy (FIGHT-214)

Not yet recruiting· Incyte logo

Incyte·Phase 2·NCT07862998·72 enrolled

A Phase 3, Open-Label, Randomized, Active-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Gemcitabine Plus Cisplatin Chemotherapy in First-Line Treatment of Participants With Unresectable or Metastatic Cholangiocarcinoma With FGFR2 Rearrangement (FIGHT-302)

Terminated· Incyte logo

Incyte·Phase 3·NCT03656536·167 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

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

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

Solid Tumors1 trial

Pemigatinib for FGF/FGFR Alterations Advanced Pan Solid Tumors

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

GIST1 trial

PH 2 Pemigatinib in SDH-deficient GIST

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

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

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

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

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

Squamous Carcinoma1 trial

Pemigatinib in Subjects With Adenosquamous Carcinoma of the Pancreas

Withdrawn·HHonorHealth Research Institute·Phase 2·NCT05216120

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

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

Recruiting·MMassachusetts General Hospital·Phase 1·NCT06302621·32 enrolled

Ampulla of Vater Carcinoma1 trial

A Phase IIa Clinical Trial of First-Line Cyclical Gemcitabine, Cisplatin, and Durvalumab Alternating With Pemigatinib for Advanced Biliary Tract Cancers With FGFR2 Alterations

Recruiting·OOhio State University Comprehensive Cancer Center·Phase 2·NCT07780838·29 enrolled

Dedifferentiated Liposarcoma1 trial

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

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

Advanced Cholangiocarcinoma1 trial

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·Preclinical·NCT06439485·25 enrolled

Acute Myeloid Leukemia1 trial

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

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

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

Feb 23, 2021

PEMAZYRE

NDA NDA213736

Aug 26, 2022

PEMAZYRE

NDA NDA213736

Sources

References

[1]
ClinicalTrials.gov — 46 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

Q4 2027

Trials by Indication[1]

Non-Small Cell Lung Cancer4 trials

Advanced Malignancies4 trials

Cholangiocarcinoma3 trials

Intrahepatic Cholangiocarcinoma2 trials

Colorectal Cancer2 trials

Pancreatic Cancer2 trials

Urothelial Carcinoma2 trials

Unresectable Cholangiocarcinoma2 trials

Immunotherapy1 trial

Intestinal Cancer1 trial

Trial1 trial

Patients With Solid Tumors1 trial

Gastric Cancer1 trial

Solid Tumors1 trial

GIST1 trial

Glioblastoma1 trial

Efficacy and Safety1 trial

Lymphoid Neoplasm1 trial

Local Therapy1 trial

Solid Tumor Malignancies1 trial

Endometrial Cancer1 trial

Squamous Carcinoma1 trial

Cancer1 trial

Immune Checkpoint Inhibitor1 trial

Cancer of Unknown Primary Site1 trial

Bladder Cancer1 trial

Safety and Efficacy1 trial

Solid Tumor1 trial

Ampulla of Vater Carcinoma1 trial

Dedifferentiated Liposarcoma1 trial

Advanced Cholangiocarcinoma1 trial

Acute Myeloid Leukemia1 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