Tabrecta

capmatinib

Table of contents

Opinion

On 22 April 2022, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Tabrecta, intended for treatment of patients with advanced non-small cell lung cancer (NSCLC) harbouring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping.

The applicant for this medicinal product is Novartis Europharm Limited.

Tabrecta will be available as 150 mg and 200 mg film-coated tablets. The active substance of Tabrecta is capmatinib, a MET inhibitor (ATC code: L01EX17) which blocks MET phosphorylation and MET-dependent downstream signalling.

The benefits of Tabrecta are its objective response rate and response duration in patients with NSCLC harbouring alterations leading to METex14 skipping. The most common side effects are peripheral oedema, nausea, fatigue, vomiting, dyspnoea and decreased appetite.

The full indication is:

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.

Tabrecta should be prescribed by physicians experienced in the use of anticancer medicinal products.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Key facts

Name
Tabrecta
Agency product number
EMEA/H/C/004845
International non-proprietary name (INN) or common name
  • capmatinib
Active substance
  • capmatinib dihydrochloride monohydrate
Therapeutic area
Carcinoma, Non-Small-Cell Lung
Date opinion adopted
22/04/2022
Company name
Novartis Europharm Limited 
Status
Positive
Application type
Initial authorisation

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