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Tabrecta (CAPMATINIB)
Tabrecta works by blocking the hepatocyte growth factor receptor, a protein that helps cancer cells grow and spread.
Capmatinib (Tabrecta), marketed by Novartis, is a targeted therapy for metastatic NSCLC with MET exon 14 skipping, positioning it in a niche but critical segment of the oncology market. Its key strength lies in its mechanism of action, which specifically blocks the hepatocyte growth factor receptor, offering a precise treatment option for this patient population. The primary risk to Capmatinib's market position is the upcoming key patent expiry in 2028, which could lead to increased competition from generics and biosimilars.
At a glance
| Generic name | CAPMATINIB |
|---|---|
| Sponsor | Novartis Pharm |
| Drug class | Kinase Inhibitor |
| Target | Hepatocyte growth factor receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2020 |
| Annual revenue | 200 |
Mechanism of action
Capmatinib is kinase inhibitor that targets MET, including the mutant variant produced by exon 14 skipping. MET exon 14 skipping results in protein with missing regulatory domain that reduces its negative regulation leading to increased downstream MET signaling. Capmatinib inhibited cancer cell growth driven by mutant MET variant lacking exon 14 at clinically achievable concentrations and demonstrated anti-tumor activity in murine tumor xenograft models derived from human lung tumors with either mutation leading to MET exon 14 skipping or MET amplification. Capmatinib inhibited the phosphorylation of MET triggered by binding of hepatocyte growth factor or by MET amplification, as well as MET-mediated phosphorylation of downstream signaling proteins and proliferation and survival of MET-dependent cancer cells.
Approved indications
- Metastatic NSCLC with MET exon 14 skipping
Common side effects
- Peripheral edema
- Nausea
- Fatigue
- Vomiting
- Dyspnea
- Decreased appetite
- Pneumonia
- Pleural effusion
- General physical health deterioration
- Peripheral swelling
- Fluid overload
- Increased blood creatinine
Key clinical trials
- Study of Capmatinib in Chinese Adult Patients With Advanced Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation (PHASE2)
- Managed Access Programs for INC280, Capmatinib
- A Study of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer (PHASE1,PHASE2)
- Study to Allow Patients Previously Participating in a Novartis Sponsored Trial to Continue Receiving Capmatinib Treatment as Single Agent or in Combination With Other Treatments or the Combination Treatment Alone (PHASE2)
- European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors (PHASE1,PHASE2)
- Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC (PHASE1)
- Molecular Profiling of Advanced Soft-tissue Sarcomas (PHASE3)
- Comparing Combinations of Targeted Drugs for Advanced Non-Small Cell Lung Cancer That Has EGFR and MET Gene Changes (A Lung-MAP Treatment Trial) (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Tabrecta CI brief — competitive landscape report
- Tabrecta updates RSS · CI watch RSS
- Novartis Pharm portfolio CI