pemigatinib
pemigatinib: sourced relationships with 1 company · 24 clinical trials tracked · 1 FDA decision.
pemigatinib evidence translation
What we can confirm
1 FDA record · 24 tracked trials
What it means
What to watch
Prepared research question
How could pemigatinib → INCY affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence8 indications · 0 study sponsors
Related indications
Study sponsors
No additional listed-company sponsor is linked.
Dated Pipeline Records (1)
| Company | Dated record stage |
|---|---|
| Incyte Corp. (INCY) Reported 2020-04-17 · Current development: unknownSource UC (Urothelial Cancer); Glioblastoma; Unresectable Cholangio… | Phase 3 |
Clinical Trial Registry Records (24)showing 10 most recent
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)
Primary endpoint: Objective Response
A Phase IIa Clinical Trial of First-Line Cyclical Gemcitabine, Cisplatin, and Durvalumab Alternating With Pemigatinib for Advanced Biliary Tract Cancers With FGFR2 Alterations
Primary endpoint: Overall survival (OS)
PEMIGIST: Phase 2 Study of Pemigatinib (INCB054828) in the Treatment of Patients With Advanced SDH-deficient Gastrointestinal Stromal Tumor (GIST)
Primary endpoint: Objective radiographic response rate
A Phase II Study of Pemigatinib Plus Durvalumab (MEDI4736) in Previously Treated Advanced Intrahepatic Cholangiocarcinoma Patients With FGFR-2 Fusion or Rearrangement
Primary endpoint: Confirmed objective response rate (ORR)
PERFORM: A Phase II Study of Pemigatinib in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphomas
Primary endpoint: Overall Response Rate (ORR) at Cycle 7 per IWG Response Criteria in subjects with R/R MCL.
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
Primary endpoint: Overall Response Rate (ORR)
Phase II Trial Evaluating the Efficacy of Pemigatinib in Patients With Recurrent and/or Metastatic Solid Tumor Harboring a FGFR Alteration
Primary endpoint: Tumor regression
Phase I/II Trial of Pemigatinib in Combination With Atezolizumab and Bevacizumab for Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion
Primary endpoint: Safety and adverse events (AEs)
A Phase Ia/Ib Study of the Combination of the FGFR Inhibitor Pemigatinib and the EGFR Inhibitor Afatinib in Advanced Refractory Solid Tumors
Primary endpoint: Maximum tolerated dose (MTD)
A Phase II Study of Pemigatinib After Curative Local Therapy in Locally Advanced Intrahepatic Cholangiocarcinoma (iCCA) Harboring FGFR2 Fusions/Rearrangements.
Primary endpoint: Objective response rate at time of progression
FDA Decisions1 records
Frequently asked questions
Which companies have sourced relationships with pemigatinib?
pemigatinib has dated SEC/FDA relationship records for Incyte Corp..
How many clinical trials involve pemigatinib?
BioSniper tracks 24 clinical trials involving pemigatinib.
What is pemigatinib's latest FDA decision?
The most recent tracked FDA decision for pemigatinib is Approval for 1 INDICATIONS AND USAGE PEMAZYRE is a kinase inhibitor indicated: for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. ( 1 , 2.1 ) This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 , 2.1 ) For the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement. ( 1 , 2.1 ) 1.1 Cholangiocarcinoma PEMAZYRE is indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test [see Dosage and Administration ( 2.1 )] . This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies ( 14.1 )]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). 1.2 Myeloid/Lymphoid Neoplasms with FGFR1 Rearrangement PEMAZYRE is indicated for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with fibroblast growth factor receptor 1 (FGFR1) rearrangement., dated April 17, 2020.