NDAORALTABLETPriority Review
Approved
May 2020
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
22
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TABRECTA (capmatinib) is an oral small-molecule MET inhibitor approved by the FDA in May 2020 for the treatment of non-small cell lung cancer (NSCLC) harboring METex14 mutations. The drug is also being investigated across multiple solid and hematological malignancies including advanced hepatocellular carcinoma, triple-negative breast cancer, glioma, gastric cancer, neuroblastoma, and soft tissue sarcoma. As a targeted therapy addressing a specific genetic driver mutation, capmatinib represents a precision medicine approach for previously underserved patient populations.
$0.1BPart D
9.2 years to LOEMechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (22)
DETERMINE Trial Treatment Arm 06: Capmatinib in Adult Patients With Cancers Harbouring MET Dysregulations
Started Nov 2024
30 enrolled
Solid TumourHaematological MalignancyMalignant Neoplasm+8 more
Central Nervous System Efficacy of Capmatinib in NSCLC With Brain Metastases With cfDNA Positive MET Alterations
Started Oct 2023
0Non-small Cell Lung Cancer
A Post Approval Commitment Study on Tabrecta® (Capmatinib) in South Korea
Started Jun 2023
250 enrolled
Non-Small-Cell Lung Carcinoma
A Study of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer
Started Dec 2022
57 enrolled
Carcinoma, Non-Small-Cell Lung
Study of Capmatinib in Indian Patients With MET Exon 14 Skipping Mutation Positive Advanced NSCLC.
Started Sep 2022
50 enrolled
Non-Small Cell Lung Carcinoma
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.