Drugs / Pemigatinib
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed cholangiocarcinoma 2 milestones | |||||
| Filed | EU (EMA) | — | cholangiocarcinoma | — | “marketing authorization application (MAA) seeking the approval of pemigatinib for patients with cholangiocarcinoma in the EU has been validated” incyte.com ↗ |
| Filed | China (NMPA) | Pemazyre® | cholangiocarcinoma | — | “In July 2021, the National Medical Products Administration (NMPA) of China accepted the New Drug Application (NDA) for Pemazyre®(pemigatinib)” innoventbio.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansion | US (FDA) | PEMAZYRE | — | 2022-08-26 | fda.gov ↗ |
| Approved · conditional | EU (EMA) | Pemazyre | — | 2021-03-26 | europa.eu ↗ |
| Approved | US (FDA) | PEMAZYRE | — | 2020-04-17 | fda.gov ↗ |
Trials 52
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT06302621 | Apr 2024 → Dec 2027 expected | cholangiocarcinoma, metastatic neoplasm | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 1 | NCT04088188 | Jan 2021 → Dec 2023 | cholangiocarcinoma | Academic and Community Cancer Research United | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT04659616 | Jan 2021 → Dec 2026 expected | acute myeloid leukemia | OHSU Knight Cancer Institute | Recruiting | No outcome recorded |
| Phase 1 | NCT04258527 | Mar → Jul 2020 | cancer | Innovent Biologics (Suzhou) Co. Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03235570 | Aug 2017 → Mar 2020 | cancer | Incyte Corporation | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT06439485 | Nov 2024 → Feb 2028 expected | cholangiocarcinoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05529667 | May 2019 → Aug 2023 | — | Yonsei University | Completed | No outcome recorded |
| Phase 1/2 | NCT02393248 | Feb 2015 → Dec 2021 | breast cancer, cholangiocarcinoma, endometrial cancer, gastric cancer +4 | Incyte Corporation | Terminated | No outcome recorded |
| Phase 241 trials · 2 met primary · 1 missed | ||||||
| Phase 2 | NCT07862998 | Dec 2026 → Feb 2031 expected | cholangiocarcinoma | Incyte Corporation | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07780838 | Nov 2026 → Dec 2027 expected | carcinoma of the ampulla of vater, distal biliary tract carcinoma, gallbladder carcinoma, intrahepatic cholangiocarcinoma | Ohio State University Comprehensive Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07802418 | Oct 2026 → Jun 2031 expected | malignant pancreatic neoplasm | Herlev Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07434843 | May 2026 → Oct 2028 expected | gastrointestinal stromal tumor, inborn mitochondrial metabolism disorder | Dana-Farber Cancer Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT06728410 | Jan 2026 → Jul 2027 expected | intrahepatic cholangiocarcinoma | Mehmet Akce | Recruiting | No outcome recorded |
| Phase 2 | NCT06300528 | Oct 2025 → Mar 2026 overdue | mantle cell lymphoma, marginal zone lymphoma | University of Utah | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06906562 | Aug 2025 → Dec 2026 expected | digestive system carcinoma | Sameek Roychowdhury | Recruiting | No outcome recorded |
| Phase 2 | NCT06653777 | Mar 2025 → Jun 2027 expected | — | UNICANCER | Recruiting | No outcome recorded |
| Phase 2 | NCT06551896 | Aug 2024 → Jul 2026 overdue | breast neoplasm, gastric cancer, lung cancer, soft tissue sarcoma +1 | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06530823 | Aug 2024 → Aug 2026 overdue | cholangiocarcinoma | Eastern Hepatobiliary Surgery Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06389799 | Jun 2024 → Dec 2027 expected | dedifferentiated liposarcoma | Lund University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05997459 | Aug 2023 → Dec 2024 | — | Sun Yat-sen University | Unknown | No outcome recorded |
| Phase 2 | NCT05913661 | Jul 2023 → Nov 2024 | intrahepatic cholangiocarcinoma | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Unknown | No outcome recorded |
| Phase 2 | NCT06022289 | May 2023 → May 2025 | cancer | Tianjin Medical University Second Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05651672 | Dec 2022 → Dec 2024 overdue | digestive system cancer | Tianjin Medical University Cancer Institute and Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05565794 | Nov 2022 → Mar 2025 | intrahepatic cholangiocarcinoma | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05560334 | Sep 2022 → Sep 2024 | breast cancer | Tianjin Medical University Cancer Institute and Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05559775 | Aug 2022 → Aug 2024 | digestive system cancer | Zhejiang Cancer Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05216120 | Jun 2022 → Aug 2024 | exocrine pancreatic carcinoma | HonorHealth Research Institute | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05267106 | May 2022 → Dec 2024 | glioblastoma | Incyte Corporation | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05253807 | Apr 2022 → Aug 2023 | non-small cell lung carcinoma | Incyte Corporation | Completed | No outcome recorded |
| Phase 2 | NCT05004974 | Apr 2022 → Sep 2023 | non-small cell lung carcinoma | The Fourth Affiliated Hospital of Zhejiang University School of Medicine | Unknown | No outcome recorded |
| Phase 2 | NCT05287386 | Jan 2022 → Jan 2024 | non-small cell lung carcinoma | The First Affiliated Hospital of Xiamen University | Unknown | No outcome recorded |
| Phase 2 | NCT05159245 | Dec 2021 → Nov 2026 expected | cancer, hematopoietic and lymphoid cell neoplasm | Helsinki University Central Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05202236 | Oct 2021 → Oct 2023 | colorectal cancer | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Unknown | No outcome recorded |
| Phase 2 | NCT04949191 | Jul 2021 → Apr 2024 | cancer | Incyte Corporation | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT04817956 | Apr 2021 → Mar 2040 expected | metastatic malignant neoplasm | Oslo University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04463771 | Jan 2021 → May 2026 | endometrial cancer | Incyte Corporation | Completed | No outcome recorded |
| Phase 2 | NCT04591431 | Oct 2020 → Dec 2024 | breast cancer, digestive system cancer, non-small cell lung carcinoma | Fondazione per la Medicina Personalizzata | Unknown | Met primary |
| Phase 2 | NCT03914794 | Oct 2020 → Sep 2025 | non-invasive bladder urothelial carcinoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | No outcome recorded |
| Phase 2 | NCT04096417 | Aug 2020 → May 2022 | colorectal carcinoma | Academic and Community Cancer Research United | Unknown | Missed primary |
| Phase 2 | NCT04294277 | Jul 2020 → Nov 2021 | urothelial carcinoma | European Association of Urology Research Foundation | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04003610 | May 2020 → Apr 2021 | urothelial carcinoma | Incyte Corporation | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT04256980 | Mar 2020 → Jan 2021 | cholangiocarcinoma | Innovent Biologics (Suzhou) Co. Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT04003623 | Oct 2019 → Jun 2020 | — | Incyte Corporation | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03822117 | Oct 2019 → Mar 2022 | cancer | Incyte Corporation | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03498521 | Jul 2018 → Feb 2023 | cancer of unknown primary site | Hoffmann-La Roche | Completed | Met primary |
| Phase 2 | NCT03011372 | Apr 2017 → Oct 2024 | myeloproliferative neoplasm | Incyte Corporation | Completed | No outcome recorded |
| Phase 2 | NCT02924376 | Jan 2017 → Feb 2022 | cholangiocarcinoma | Incyte Corporation | Completed | No outcome recorded |
| Phase 2 | NCT02872714 | Jan 2017 → Feb 2022 | urothelial carcinoma | Incyte Corporation | Completed | No outcome recorded |
| Phase 2 | NCT02925234 | Aug 2016 → Sep 2027 expected | cancer | The Netherlands Cancer Institute | Recruiting | Mixed |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT03656536 | Jun 2019 → Jul 2025 | cholangiocarcinoma | Incyte Corporation | Terminated | Met primary Stop: Enrollment |
| Phase not applicable1 trial | ||||||
| — | NCT05210946 | Dec 2021 → Dec 2023 | non-small cell lung carcinoma | The First Affiliated Hospital of Soochow University | Unknown | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT03906357 | — | — | Incyte Corporation | No longer available | No outcome recorded |
News releases announcing trial results or a regulatory action · 21
| Date | Issuer | Release |
|---|---|---|
| 2023-04-20 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent Announces Overall Survival Results of Phase 2 Study of Pemazyre® (pemigatinib) in Chinese Patients with Advanced Cholangiocarcinoma Presented at AACR Annual Meeting 2023 innoventbio.com ↗
Among 30 efficacy evaluable subjects (1 participant excluded due to inadequate FGFR2 aberrant frequency), the median follow-up was 25.6 months (95% CI, 23.0-25.8), the median OS was 23.9 months (95% CI, 15.2-NC) with 16 (53.3%) OS events. |
| 2023-03-27 | Incyte Corporation | Regulatory Incyte Announces Japanese Approval of Pemazyre® (pemigatinib) for the Treatment of Patients with Myeloid/Lymphoid Neoplasms (MLNs) incyte.com ↗
Incyte (Nasdaq:INCY) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Pemazyre® (pemigatinib), a selective fibroblast growth factor receptor (FGFR) inhibitor, for the treatment of myeloid/lymphoid neoplasms (MLNs) with FGFR1 fusion (also known as 8p11 myeloproliferative syndrome). |
| 2022-08-26 | Incyte Corporation | Regulatory Incyte Announces FDA Approval of Pemazyre® (pemigatinib) as the First and Only Targeted Treatment for Myeloid/Lymphoid Neoplasms (MLNs) with FGFR1 Rearrangement incyte.com ↗
Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Pemazyre® (pemigatinib), a selective fibroblast growth factor receptor (FGFR) inhibitor, for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement. |
| 2022-04-06 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Innovent Announces the Approval of Pemazyre® (pemigatinib) by the NMPA for the Treatment of Adults with Locally Advanced or Metastatic Cholangiocarcinoma with A FGFR2 Fusion or Rearrangement As Confirmed By A Validated Diagnostic Test That Have Progressed innoventbio.com ↗
the National Medical Products Administration (NMPA) has approved Pemazyre® (pemigatinib) |
| 2022-01-25 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Innovent Announces the Approval of Pemazyre® (pemigatinib) in Hong Kong Market for the Treatment of Adults With Locally Advanced Or Metastatic Cholangiocarcinoma With A FGFR2 Fusion Or Rearrangement That Have Progressed After At Least One Prior Line Of Sy innoventbio.com ↗
announced that the Hong Kong Department of Health (DH) has approved Pemazyre® (pemigatinib) |
| 2021-09-17 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent Releases Phase 2 Results of Pemigatinib in Chinese Patients with Advanced Cholangiocarcinoma at ESMO Congress 2021 innoventbio.com ↗
Innovent Biologics, Inc. (“Innovent”, HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, announced that the results of the Phase 2 study in Chinese patients with advanced cholangiocarcinoma were released today at the European Society for Medical Oncology (ESMO) Congress 2021 ( E-poster # 50P). |
| 2021-07-09 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Innovent Announces NMPA Acceptance of New Drug Application for the FGFR1/2/3 Inhibitor (Pemigatinib) for the Treatment of Adults with Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma with a FGFR2 Fusion or Rearrangement innoventbio.com ↗ |
| 2021-06-22 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Innovent Announces the Approval of Pemazyre® (pemigatinib) in Taiwan Market for the Treatment of Adults with Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma with a FGFR2 Fusion or Rearrangement innoventbio.com ↗
Pemazyre, discovered by Incyte and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan, is the first tyrosine kinase inhibitor approved for the treatment of cholangiocarcinoma, a type of biliary tract cancer, in Taiwan market. |
| 2021-06-07 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent Releases Phase 1 Results of Pemigatinib in Chinese Patients with Advanced Solid Tumors at ASCO Annual Meeting 2021 innoventbio.com ↗
Innovent Biologics, Inc. (“Innovent”, HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, announced that the results of the Phase 1 study in Chinese patients with advanced solid tumors were released today at the American Society for Clinical Oncology (ASCO) Annual Meeting 2021. |
| 2021-03-29 | Incyte Corporation | Regulatory Incyte Announces the European Commission Approval of Pemazyre® (pemigatinib) as a Treatment for Adults with Locally Advanced or Metastatic Cholangiocarcinoma with a Fibroblast Growth Factor Receptor 2 (FGFR2) Fusion or Rearrangement incyte.com ↗
Pemazyre is the first targeted therapy approved in the EU for this indication |
| 2021-03-23 | Incyte Corporation | Regulatory Incyte Announces Approval of Pemazyre® (pemigatinib) in Japan for the Treatment of Patients with Unresectable Biliary Tract Cancer (BTC) with a Fibroblast Growth Factor Receptor 2 (FGFR2) Fusion Gene, Worsening After Cancer Chemotherapy incyte.com ↗
“The MHLW approval of Pemazyre is an important milestone for the BTC community, and underscores our commitment to finding and delivering solutions for patients with significant unmet medical needs,” said Lothar Finke, M.D., Ph.D., General Manager, Incyte Asia. |
| 2021-01-29 | Incyte Corporation | Regulatory Incyte Announces Positive CHMP Opinion for Pemigatinib for the Treatment of Adults With Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma With a Fibroblast Growth Factor Receptor 2 (FGFR2) Fusion or Rearrangement incyte.com ↗ |
| 2020-04-20 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Innovent Biologics Announces FDA Approval of Pemazyre™ (Pemigatinib) as First Targeted Treatment for Adults with Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma innoventbio.com ↗
Pemazyre is the first and only FDA-approved treatment for this indication, which was approved under accelerated approval based on overall response rate and duration of response (DOR). |
| 2020-04-17 | Incyte Corporation | Regulatory FDA Approves Incyte’s Pemazyre™ (pemigatinib) as First Targeted Treatment for Adults with Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma incyte.com ↗
Pemazyre is the first and only FDA-approved treatment for this indication, which was approved under accelerated approval based on overall response rate and duration of response (DOR). |
| 2020-01-07 | Incyte Corporation | Regulatory Incyte Announces the Validation by the European Medicines Agency of its Marketing Authorization Application for Pemigatinib in Patients with Cholangiocarcinoma incyte.com ↗
Incyte (Nasdaq:INCY) today announced the validation of the Company’s Marketing Authorization Application (MAA) for pemigatinib for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that is relapsed or refractory after at least one line of systemic therapy. |
| 2019-12-02 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Innovent Biologics Announces FDA Acceptance of NDA for Pemigatinib in Patients with Previously Treated, Locally Advanced or Metastatic Cholangiocarcinoma with FGFR2 Fusions or Rearrangements innoventbio.com ↗ |
| 2019-11-27 | Incyte Corporation | Regulatory Incyte Announces Acceptance and Priority Review of NDA for Pemigatinib as a Treatment for Patients with Cholangiocarcinoma incyte.com ↗
the U.S. Food and Drug Administration (FDA) has accepted for Priority Review its New Drug Application (NDA) for pemigatinib |
| 2019-10-29 | Incyte Corporation | Regulatory Incyte Reports 2019 Third Quarter Financial Results and Provides Updates on Key Clinical Programs incyte.com ↗
The NDA seeking approval for pemigatinib as a second-line treatment for cholangiocarcinoma patients with FGFR2 fusions or rearrangements was submitted to the U.S. Food and Drug Administration (FDA) under Breakthrough Therapy designation. |
| 2019-10-21 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent Biologics Announces Positive Updated Result from the Incyte-sponsored Phase II Trial of Pemigatinib in Patients with Previously Treated, Advanced Cholangiocarcinoma innoventbio.com ↗
Pemigatinib was generally well tolerated. |
| 2019-09-27 | Incyte Corporation | Results Incyte Announces Positive Updated Results from Phase 2 Trial of Pemigatinib in Patients with Previously Treated, Advanced Cholangiocarcinoma incyte.com ↗
In patients harboring FGFR2 fusions or rearrangements (Cohort A), pemigatinib monotherapy resulted in an overall response rate (ORR) of 36 percent (primary endpoint), and median progression free survival (PFS) of 6.9 months (secondary endpoint) with a median follow-up of 15 months. |
| 2018-10-21 | Incyte Corporation | Results Incyte Announces Positive Interim Data from Phase 2 Trial of Pemigatinib, Its Selective FGFR Inhibitor, in Patients with Cholangiocarcinoma incyte.com ↗ |
All press releases naming this drug 27 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 55 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Pemigatinib | “Axitinib Crizotinib Dabrafenib Trametinib Erlotinib Larotrectinib Olaparib Pembrolizumab Pemigatinib Pertuzumab and trastuzumab (Phesgo9 Selpercatinib Vismodegib” NCT07802418 ↗ |
| Known as | Fgfr inhibitor incb054828 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297522 ↗ |
| Known as | INCB054828 | “Pemigatinib (INCB054828)” NCT03011372 ↗ |
| Known as | Pemazyre | “Pemazyre used outside ofcurrent indication” NCT04817956 ↗ |
| Action | Inhibit | “potent and selective fibroblast growth factor receptor (FGFR) 1-3 inhibitor” PMID 35176457 ↗ Feb 2022 |
| Modality | Small molecule | — CHEMBL4297522 ↗ |
| Route | Oral | “Participants self-administered oral pemigatinib 1/2/4 milligrams (mg) once daily (QD)” NCT02393248 ↗ |
| Target | FGFR1 | “BACKGROUND: Fibroblast growth factor receptor 3 (FGFR3) alterations are oncogenic drivers of urothelial carcinoma (UC). Pemigatinib is a selective, oral inhibitor of FGFR1-3...” PMID 37956738 ↗ Nov 2023 |
| Target | FGFR3 | “BACKGROUND: Fibroblast growth factor receptor 3 (FGFR3) alterations are oncogenic drivers of urothelial carcinoma (UC). Pemigatinib is a selective, oral inhibitor of FGFR1-3...” PMID 37956738 ↗ Nov 2023 |