Novartis receives approval from the European Commission for Tabrecta for the treatment of non-small cell lung cancer
Novartis has announced that the European Commission (EC) has approved Tabrecta – also known as capmatinib – as a monotherapy for the treatment of adults with advanced non-small cell lung cancer (NSCLC).
It specifically involves patients who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.
The approval follows a positive opinion issued in April by the Committee for Medicinal Products for Human Use of the European Medicines Agency and is applicable to all 27 European Union member states plus Iceland, Norway and Liechtenstein.
The approval is based on results from the phase 2 GEOMETRY mono-1 trial that demonstrated positive overall response rates among adult patients with advanced NSCLC whose tumours had alterations leading to METex14 skipping.
“Patients with METex14 skipping alterations typically have a more advanced form of lung cancer that is often associated with a poor prognosis and limited response to standard therapy, including immunotherapy,” said Juergen Wolf, from the Center for Integrated Oncology, University Hospital Cologne, Germany.
“With the approval of Tabrecta in Europe, supported by advances in biomarker testing that can help doctors direct treatment more precisely, patients with this specific genomic profile have a new targeted treatment option that can lead to improved outcomes,” he added
In the European Union, there are an estimated 291,000 patients with locally advanced or metastatic NSCLC. Tabrecta is also approved in several countries including the US, Switzerland and Japan.