TABRECTA
TABRECTA (capmatinib hydrochloride) is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC). It is specifically used for patients whose tumors harbor a mutation leading to mesenchymal-epithelial transition (MET) exon 14 skipping. Treatment eligibility is determined by the presence of this mutation as detected by an FDA-approved test. This medication provides a targeted therapeutic option for patients with this specific genetic alteration.
How TABRECTA Works
Capmatinib targets the MET receptor, including the mutant variant produced by exon 14 skipping. This mutation results in a protein missing a regulatory domain, which leads to increased downstream signaling and tumor cell growth. By inhibiting MET phosphorylation and downstream signaling proteins, the drug prevents the proliferation and survival of MET-dependent cancer cells. It has demonstrated anti-tumor activity in models with mutations leading to MET exon 14 skipping or MET amplification.
Details
- Status
- Prescription
- First Approved
- 2020-05-06
- Routes
- ORAL
- Dosage Forms
- TABLET
TABRECTA Approval History
What TABRECTA Treats
1 indicationsTABRECTA is approved for 1 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Metastatic non-small cell lung cancer (NSCLC) with a mutation leading to mesenchymal-epithelial transition (MET) exon 14 skipping
TABRECTA Competitors
Pro8 other drugs also target MET. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (MET). Earlier expiry dates signal biosimilar/generic opportunities.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TABRECTA FDA Label Details
ProIndications & Usage
FDA Label (PDF)TABRECTA is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test. TABRECTA is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.
TABRECTA Patents & Exclusivity
Patents (28 active)
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.