Tabrecta (capmatinib)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- capmatinib
- Company
- Novartis Europharm Limited
- Status
- Authorised
- Therapeutic area
- Carcinoma, Non-Small-Cell Lung
- CHMP opinion
- Fri 22 Apr 2022
- EU approval
- Mon 20 Jun 2022
- Designations
- Additional monitoring
- Application
- EMEA/H/C/004845
- ATC
- L01EX17
- Official record
- www.ema.europa.eu
Indication
Tabrecta as monotherapy is indicated for the treatment of adult patients with advanced non small cell lung cancer (NSCLC) harbouring alterations leading to mesenchymal epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum based chemotherapy.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.