Drugs / Capmatinib
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Capmatinib

Small molecule targets MET via inhibition

Developed for
non-small cell lung carcinoma · hepatocellular carcinoma · cancer · colorectal cancer · hematopoietic and lymphoid cell neoplasm · melanoma · soft tissue sarcoma · breast cancer
+18 more · childhood malignant neoplasm · cutaneous melanoma · esophageal adenocarcinoma · gastric adenocarcinoma · gastric cancer · glioma · head and neck squamous cell carcinoma · high grade astrocytic tumor · kidney cancer · lung adenocarcinoma · lung cancer · metastatic malignant neoplasm · metastatic neoplasm · neoplasm · neuroblastoma · squamous cell lung carcinoma · triple-negative breast carcinoma · glioblastoma
Investigated by
Novartis Pharmaceuticals · Novartis · Cancer Research UK · National Cancer Institute (NCI) · Royal Marsden NHS Foundation Trust · University of Birmingham
+44 more · University of Manchester · Asan Medical Center · Assistance Publique - Hôpitaux de Paris · Celcuity Inc · Collin Blakely · EUCLID Clinical Trial Platform · Fight Kids Cancer · Fondation ARC · French Alternative Energies and Atomic Energy Commission · French National Institute of Health and Medical Research · Gustave Roussy, Cancer Campus, Grand Paris · Haukeland University Hospital · Helse Fonna · Helse Forde · Helse Møre og Romsdal HF · Helse Nord-Trøndelag HF · Helse Stavanger HF · Hoffmann-La Roche · Hospital of Southern Norway Trust · Innlandet Hospital Trust · Institut Bergonié · Janssen Research & Development, LLC · Lovisenberg Diakonale Hospital · M.D. Anderson Cancer Center · Massachusetts General Hospital · National Cancer Institute, France · Nordland Hospital · Oslo University Hospital · Ostfold Hospital Trust · Pfizer · Plateforme labellisée Inca - Hôpital Européen Georges Pompidou, Paris · Plateforme labellisée Inca - Institut Bergonié, Bordeaux · Puma Biotechnology, Inc. · SCRI Development Innovations, LLC · St. Olavs Hospital · Sun Yat-sen University · Sykehuset Telemark · The Hospital of Vestfold · Timothy Burns, MD, PHD · University Hospital of North Norway · University Hospital, Akershus · University of California, Davis · University of California, San Francisco · Vestre Viken Hospital Trust

Regulatory milestones approvals, filings & regulatory actions · 5 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed non-small cell lung carcinoma 2 milestones
Filed Japan (PMDA) — non-small cell lung carcinoma 2020-05-29

“Novartis Japan K.K. has submitted the regulatory application of capmatinib to the MHLW.” chugai-pharm.co.jp ↗

Filed US (FDA) — non-small cell lung carcinoma —

“Capmatinib (INC280) was submitted to FDA with breakthrough therapy designation for NSCLC.” novartis.com ↗

Approved Indication not stated 3 milestones
Label expansion US (FDA) TABRECTA — 2022-08-10 fda.gov ↗
Approved EU (EMA) Tabrecta — 2022-06-20 europa.eu ↗
Approved US (FDA) TABRECTA — 2020-05-06 fda.gov ↗

Trials 49

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 113 trials
Phase 1 NCT05435846 Aug 2022 → Nov 2023 non-small cell lung carcinoma Collin Blakely Terminated No outcome recorded Stop: Enrollment
Phase 1 NCT03742349 Jan 2019 → Feb 2023 triple-negative breast carcinoma Novartis Pharmaceuticals Terminated No outcome recorded Stop: Business
Phase 1 NCT03333343 Jan 2018 → Oct 2026 expected non-small cell lung carcinoma Novartis Pharmaceuticals Active not recruiting No outcome recorded
Phase 1 NCT02925104 Dec 2016 → May 2018 neoplasm Novartis Pharmaceuticals Completed No outcome recorded
Phase 1 NCT02520752 Dec 2015 → Jan 2017 — Novartis Pharmaceuticals Completed No outcome recorded
Phase 1 NCT02626234 Dec 2015 → Feb 2017 — Novartis Pharmaceuticals Completed No outcome recorded
Phase 1 NCT02468661 Sep 2015 → Nov 2017 non-small cell lung carcinoma Novartis Pharmaceuticals Terminated No outcome recorded Stop: Enrollment
Phase 1 NCT02386826 Sep 2015 → Jul 2021 colorectal cancer, gliosarcoma, renal cell carcinoma SCRI Development Innovations, LLC Completed No outcome recorded
Phase 1 NCT02474537 Jun 2015 → Aug 2017 — Novartis Pharmaceuticals Completed No outcome recorded
Phase 1 NCT02205398 Jul 2014 → Jan 2017 colorectal cancer, head and neck squamous cell carcinoma Novartis Pharmaceuticals Terminated No outcome recorded
Phase 1/26 trials · 1 missed
Phase 1/2 NCT05488314 Dec 2022 → Apr 2027 expected non-small cell lung carcinoma Janssen Research & Development, LLC Active not recruiting No outcome recorded
Phase 1/2 NCT05243641 Aug 2022 → Nov 2024 breast cancer, metastatic neoplasm M.D. Anderson Cancer Center Terminated No outcome recorded
Phase 1/2 NCT02813135 Aug 2016 → Feb 2031 expected childhood malignant neoplasm Gustave Roussy, Cancer Campus, Grand Paris Recruiting No outcome recorded
Phase 1/2 NCT02795429 Jun 2016 → Jun 2021 hepatocellular carcinoma Novartis Pharmaceuticals Completed Missed primary
Phase 1/2 NCT02335944 Jan 2015 → Nov 2020 non-small cell lung carcinoma Novartis Pharmaceuticals Terminated No outcome recorded
Phase 1/2 NCT01870726 Jan 2014 → Dec 2016 high grade astrocytic tumor Novartis Pharmaceuticals Terminated No outcome recorded
Phase 224 trials · 1 met primary
Phase 2 NCT06054191 Feb 2024 → Mar 2025 overdue non-small cell lung carcinoma Sun Yat-sen University Not yet recruiting No outcome recorded
Phase 2 NCT05567055 Oct 2023 → Sep 2026 non-small cell lung carcinoma Timothy Burns, MD, PHD Withdrawn No outcome recorded Stop: Enrollment
Phase 2 NCT04926831 Aug 2022 → Mar 2024 non-small cell lung carcinoma Novartis Pharmaceuticals Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT05135845 Mar 2022 → Apr 2023 esophageal adenocarcinoma, gastric adenocarcinoma Assistance Publique - Hôpitaux de Paris Suspended No outcome recorded Stop: Business
Phase 2 NCT04677595 May 2021 → Oct 2023 non-small cell lung carcinoma Novartis Pharmaceuticals Completed No outcome recorded
Phase 2 NCT04817956 Apr 2021 → Mar 2040 expected metastatic malignant neoplasm Oslo University Hospital Recruiting No outcome recorded
Phase 2 NCT04460729 Nov 2020 → Nov 2023 non-small cell lung carcinoma Novartis Pharmaceuticals Withdrawn No outcome recorded
Phase 2 NCT04323436 Aug 2020 → Dec 2022 non-small cell lung carcinoma Novartis Pharmaceuticals Terminated No outcome recorded Stop: Business
Phase 2 NCT04139317 Jan 2020 → Jan 2022 non-small cell lung carcinoma Novartis Pharmaceuticals Terminated No outcome recorded Stop: Business
Phase 2 NCT03647488 Dec 2018 → Sep 2020 non-small cell lung carcinoma Novartis Pharmaceuticals Completed No outcome recorded
Phase 2/32 trials
Phase 2/3 NCT06988475 Nov 2024 → Oct 2029 expected gastric cancer, glioma, hematopoietic and lymphoid cell neoplasm, neuroblastoma +1 Cancer Research UK Recruiting No outcome recorded
Phase 2/3 NCT05722886 Mar 2023 → Oct 2029 expected cancer, hematopoietic and lymphoid cell neoplasm Cancer Research UK Recruiting No outcome recorded
Phase 33 trials
Phase 3 NCT04816214 Sep 2021 → Dec 2022 non-small cell lung carcinoma Novartis Pharmaceuticals Terminated No outcome recorded Stop: Business
Phase 3 NCT04427072 Sep 2020 → Feb 2023 non-small cell lung carcinoma Novartis Pharmaceuticals Terminated No outcome recorded
Phase 3 NCT03784014 Oct 2019 → Dec 2023 soft tissue sarcoma French National Institute of Health and Medical Research Completed No outcome recorded
Phase 41 trial
Phase 4 NCT05110196 Sep 2022 → Aug 2025 non-small cell lung carcinoma Novartis Pharmaceuticals Completed No outcome recorded
Comparator or background therapy2 trials
Phase 2 NCT05642572 Background May 2023 → Jun 2027 expected non-small cell lung carcinoma SWOG Cancer Research Network Recruiting No outcome recorded
— NCT04741789 Background — non-small cell lung carcinoma Novartis Pharmaceuticals No longer available No outcome recorded

News releases announcing trial results or a regulatory action · 20

DateIssuerRelease
2024-05-23 Janssen Research & Development, LLC Results Johnson & Johnson advances leadership in oncology innovation with more than 75 clinical study and real-world presentations at ASCO and EHA jnj.com ↗
Amivantamab plus capmatinib in advanced NSCLC harboring MET alterations: Identification of the recommended Phase 2 combination dose and preliminary dose-escalation results from the Phase 1/2 METalmark study
2022-06-22 Novartis Pharmaceuticals Regulatory Novartis receives European Commission approval for Tabrecta® for the treatment of METex14 skipping advanced non-small cell lung cancer novartis.com ↗
2022-04-22 Novartis Pharmaceuticals Regulatory Novartis receives positive CHMP opinion for Tabrecta® for patients with METex14 advanced non-small cell lung cancer novartis.com ↗
2022-04-22 Incyte Corporation Regulatory Incyte Announces Positive CHMP Opinion for Capmatinib (Tabrecta®) for the Treatment of METex14 Advanced Non-Small Cell Lung Cancer incyte.com ↗
2021-06-04 Novartis Pharmaceuticals Results Novartis announces Tabrecta® first published overall survival and updated overall response data in patients with METex14 metastatic NSCLC novartis.com ↗
Tabrecta ® (capmatinib) showed a median overall survival (OS) of 20.8 months in treatment-naïve patients and 13.6 months in previously-treated patients in first published mature data
2020-09-02 Novartis Pharmaceuticals Results Novartis announces NEJM publication of pivotal study of Tabrecta™ in patients with METex14 metastatic non-small cell lung cancer novartis.com ↗
Positive duration of response (DOR) was also observed 1 .
2020-09-02 Incyte Corporation Results Incyte Announces Pivotal GEOMETRY mono-1 Study Results of Capmatinib (Tabrecta™) in Patients with METex14 Metastatic Non-Small Cell Lung Cancer Published in NEJM incyte.com ↗
2020-06-29 Novartis Pharmaceuticals Regulatory Novartis receives simultaneous approval for five new products from Japanese Ministry of Health, Labour and Welfare, offering Japanese patients a broad range of novel treatment options novartis.com ↗
2020-06-29 Novartis Pharmaceuticals Regulatory Novartis announces MET inhibitor Tabrecta™ approved in Japan for advanced non-small cell lung cancer with METex14 novartis.com ↗
Tabrecta is approved for first-line and previously treated patients, regardless of prior treatment type.
2020-06-29 Incyte Corporation Regulatory Incyte Announces Approval of Tabrecta™ (capmatinib) in Japan for the Treatment of Patients with Advanced Non-Small Cell Lung Cancer with METex14 incyte.com ↗
Incyte (Nasdaq: INCY) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved Tabrecta™ (capmatinib) for MET exon 14 skipping (METex14) mutation-positive advanced and/or recurrent unresectable non-small cell lung cancer (NSCLC).
2020-05-06 Novartis Pharmaceuticals Regulatory Novartis announces FDA approval of MET inhibitor Tabrecta™ for metastatic non-small cell lung cancer with METex14 novartis.com ↗
2020-05-06 Incyte Corporation Regulatory Incyte Announces FDA Approval of Tabrecta™ (capmatinib) for the Treatment of Patients with Metastatic Non-Small Cell Lung Cancer with METex14 incyte.com ↗
Tabrecta is the first and only U.S. Food and Drug Administration (FDA)-approved treatment for adult patients with metastatic non-small cell lung cancer (NSCLC) with a mutation that leads to MET exon 14 skipping (METex14)

All press releases naming this drug 24 releases

DateIssuerRelease

Evidence & citations 20 cited values

Every value below carries the sentence it was read from. 55 sources stand behind the page.

FieldValueCited text
Known as capmatinib “Pharmacokinetics and safety of capmatinib with food in patients with” PMID 34053700 ↗ May 2021
31

“INC280 (capmatinib)” PMID 31776899 ↗ Nov 2019

“Capmatinib” NCT04817956 ↗

NCT04816214 ↗

NCT05243641 ↗

NCT02414139 ↗

NCT04677595 ↗

NCT02335944 ↗

NCT04741789 ↗

NCT02587650 ↗

NCT03693339 ↗

Show 21 more sources

Known as CAPMATINIB (INCB28060) ChEMBL registry synonym — accepted as the source's own label CHEMBL3188267 ↗
Known as Capmatinib dihydrochloride monohydrate ChEMBL registry synonym — accepted as the source's own label CHEMBL3188267 ↗
Known as CAPMATINIB HYDROCHLORIDE ChEMBL registry synonym — accepted as the source's own label CHEMBL3188267 ↗
Known as Capmatinib hydrochloride hydrate ChEMBL registry synonym — accepted as the source's own label CHEMBL3188267 ↗
Known as Capmatinib hydrochloride monohydrate ChEMBL registry synonym — accepted as the source's own label CHEMBL3188267 ↗
Known as INC280 “Capmatinib (INC280)” NCT02750215 ↗
20

NCT02276027 ↗

NCT01964235 ↗

NCT01737827 ↗

NCT02468661 ↗

NCT03240393 ↗

NCT02323126 ↗

NCT01870726 ↗

NCT02205398 ↗

NCT02019693 ↗

NCT01546428 ↗

Show 10 more sources

Known as INCB 28060 ChEMBL registry synonym — accepted as the source's own label CHEMBL3188267 ↗
Known as INCB-28060 FREE BASE ChEMBL registry synonym — accepted as the source's own label CHEMBL3188267 ↗
Known as INCB-28060A-1419 ChEMBL registry synonym — accepted as the source's own label CHEMBL3188267 ↗
Known as NVP-INC280 ChEMBL registry synonym — accepted as the source's own label CHEMBL3188267 ↗
Known as NVP-INC280-AAA ChEMBL registry synonym — accepted as the source's own label CHEMBL3188267 ↗
Known as NVP-INC280-NX ChEMBL registry synonym — accepted as the source's own label CHEMBL3188267 ↗
Known as NYP-INC280-NX ChEMBL registry synonym — accepted as the source's own label CHEMBL3188267 ↗
Known as Rahika “The Drugs Controller General of India (DCGI) granted approval for Rahika® (capmatinib) film-coated tablets (150 mg and 200 mg) for the treatment of adult patients with advanced...” NCT05110196 ↗
Known as Tabrecta ChEMBL registry synonym — accepted as the source's own label CHEMBL3188267 ↗
Action Inhibit “MET inhibitor” PMID 32240796 ↗ Mar 2020
Modality Small molecule — CHEMBL3188267 ↗
Route Oral “Capmatinib is an oral, ATP-competitive, and highly potent, type 1b MET inhibitor.” PMID 31778267 ↗ Dec 2019
Target MET “MET inhibitor” PMID 32240796 ↗ Mar 2020