Capmatinib
Also known as Tabrecta, Capmatinib hydrochloride
NOVARTIS AG NVS NVSEF · Carcinoma, Non-Small-Cell Lung
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Approved
Not recorded
Linked trials
2
From ClinicalTrials.gov
Latest FDA action
Approved
NDA213591,
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- NOVARTIS AG NVS NVSEF Source: Company record for NOVARTIS AG (opens in a new tab)
- Indication
- Carcinoma, Non-Small-Cell Lung Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Application
- NDA 213591 · Priority review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 213591 (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 CompletedFirst trial start 25 Sep 20202 linked trials
- Filed Completed
- Approved Current stageFirst approval 6 May 2020
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for Capmatinib. Editors add each one with its source.
Filed application
No filed application is on record for Capmatinib. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Capmatinib.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT04816214ClinicalTrials.gov record for NCT04816214 (opens in a new tab)GEOMETRY-E | Study Evaluating Efficacy and Safety of Capmatinib in Combination With Osimertinib in Adult Subjects With Non-small Cell Lung Cancers as Second Line Therapy | Phase 3 | Terminated | 6 (actual) | 27 Dec 2022 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT04816214 (opens in a new tab) |
Posted results on ClinicalTrials.gov for GEOMETRY-E Serious adverse events (From first dose of treatment until 30 days after last dose of study treatment, assessed up to 39 weeks.): Run-in Part: Capmatinib + Osimertinib 2 of 6 Source: ClinicalTrials.gov results for NCT04816214 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. | ||||||
| NCT04427072ClinicalTrials.gov record for NCT04427072 (opens in a new tab)GeoMETry-III | Study of Capmatinib Efficacy in Comparison With Docetaxel in Previously Treated Participants With Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation | Phase 3 | Terminated | 22 (actual) | 15 Feb 2023 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT04427072 (opens in a new tab) |
Posted results on ClinicalTrials.gov for GeoMETry-III Serious adverse events (From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs.): Capmatinib (On-treatment) 3 of 15; Docetaxel (On-treatment) 2 of 6; Capmatinib Extension Crossover Treatment (On-treatment) 1 of 5; Capmatinib (Post-treatment Survival Follow-up) 0 of 0; Docetaxel (Post-treatment Survival Follow-up) 0 of 0 Source: ClinicalTrials.gov results for NCT04427072 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. | ||||||
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
| Application | Action | Date | Outcome | Review | Source |
|---|---|---|---|---|---|
| NDA213591Action letter for NDA213591 (opens in a new tab) | Supplement 4 Efficacy | Approved | priority | Drugs@FDA via openFDA (opens in a new tab) | |
| NDA213591Action letter for NDA213591 (opens in a new tab) | Original 1 Type 1 - New Molecular Entity | Approved | priority | Drugs@FDA via openFDA (opens in a new tab) |
Data provided by the U.S. Food and Drug Administration.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
Authorised
Tabrecta (EMEA/H/C/004845)
- Authorised
- Therapeutic area
- Carcinoma, Non-Small-Cell Lung
- Marketing authorisation holder
- Novartis Europharm Limited
- Active substance (INN)
- capmatinib
- ATC code
- L01EX17
- Latest EMA decision
Matched by active substance: EMA's INN or active substance equals this drug's name.
EMA page for Tabrecta (opens in a new tab)EMA medicine data (opens in a new tab)
Source: European Medicines Agency (EMA), medicines data download. Licence: EMA re-use with acknowledgement. EMA medicines report 2026-10-26.
Related news
No recent headlines mention this drug.
Sources
- Drugs@FDA 213591 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT04816214 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT04427072 (opens in a new tab) Licence: public-domain. Fetched
- Drugs@FDA via openFDA NDA213591 (opens in a new tab) Licence: cc0. Fetched
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.