First targeted therapy for aggressive form of lung cancer approved by FDA

Late Wednesday, the US Food and Drug Administration said it has granted accelerated approved for Tabrecta (capmatinib; INC280) for the treatment of adult patients with non-small cell lung cancer (NSCLC) that has spread to other parts of the body.

Tabrecta, from Swiss pharma giant Novartis (NOVN: VX), is the first FDA-approved therapy to treat NSCLC with specific mutations (those that lead to mesenchymal-epithelial transition or MET exon 14 skipping). “This patient population now has an option for a targeted therapy, which they didn’t have prior today,” commented Dr Richard Pazdur, director of the FDA’s Office of Oncologic Diseases.

This approval fills a long-recognized and urgent need among METex14 patients who have not had a treatment option approved to specifically target the driver of their lung cancer. Tabrecta is approved for first-line and previously treated patients, regardless of prior treatment type, and is expected to be available to patients in the coming days.