Novartis’ Tabrecta Gained EU Approval for Advanced NSCLC

Novartis’ Tabrecta (capmatinib) has gained EU approval for treatment of adults with advanced nonsmall-cell lung cancer (NSCLC) with certain gene alterations who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

The approval is for patients with exon 14 skipping in the MET gene, a mutation present in about 3 percent of NSCLCs.

The approval, which follows a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) in April 2022, was based on results from a phase 2 study with an overall response rate of 44 percent in 100 participants.

In May 2020, the oral kinase inhibitor received accelerated approval from the FDA, which requires the company to conduct confirmatory studies to gain the agency’s full approval.