FDA Approves Novartis’ Tabrecta in Metastatic NSCLC

The FDA has granted a full approval to Novartis’ Tabrecta (capmatinib) in adult patients with metastatic nonsmall-cell lung cancer (NSCLC) whose tumors have an abnormal mesenchymal-epithelial transition (MET) gene.

The drug gained the agency’s accelerated approval for the indication in May 2020. The conversion to regular approval was based on data from an additional 63 patients and an additional 22 months of follow-up time to assess durability of response and verify clinical benefit.

The Accelerated Approval program allows for earlier approval of drugs that treat serious conditions and that fill an unmet medical need, based on achieving surrogate endpoints in clinical trials.