The treatment is intended for patients with NSCLC harbouring alterations leading to mesenchymal-epithelial-transition factor gene (MET) exon 14 (METex14) skipping and for those who need systemic therapy after previous treatment with immunotherapy and/or platinum-based chemotherapy.
A kinase inhibitor, Tabrecta acts on MET. It was discovered by Incyte and licensed to Novartis in 2009.
The latest development comes after the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) provided a positive opinion in April this year.
Tabrecta can now be used in all 27 member states of the European Union as well as Liechtenstein, Iceland and Norway.
The EC approval is based on positive findings from the Phase II GEOMETRY mono-1 clinical trial of Tabrecta in patients with advanced NSCLC harbouring alterations leading to METex14 skipping.
According to the trial data, a confirmed overall response rate (ORR) of 51.6% was attained among 31 subjects treated with Tabrecta as second- or later-line treatment in the METex14 skipping pretreated population.
Furthermore, the ORR of 44% was reported across all 100 priorly treated subjects, which included those who received one or more prior lines of systemic therapy.
Peripheral oedema, fatigue, nausea, elevated blood creatinine, vomiting, dyspnea, reduced appetite and back pain were observed to be the most frequent treatment-linked adverse events (AEs) in the trial.
Novartis Innovative Medicines International president and chief commercial officer Marie-France Tschudin said: “As the leading cause of cancer-related deaths worldwide, lung cancer can be a devastating diagnosis for patients and their families.
“With this new targeted therapy that treats a specific mutation driving cancer growth, we are delivering a much-needed treatment option and bringing hope to patients with this challenging disease.”