Tabrecta Approved for Lung Cancer

May 7, 2020 – The U.S. FDA has approved TabrectaTM (capmatinib), manufactured by Novartis, to treat adult patients who have metastatic non-small cell lung cancer (NSCLC) and whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping, as detected by an FDA-approved test.

NSCLC accounts for the majority of new lung cancer cases worldwide and about 228,000 new cases annually in the United States. Almost 70% of NSCLC patients have a genetic mutation associated with the disease. The MET exon 14 skipping mutation is a recognized driver of the disease and occurs in up to 4% of newly diagnosed metastatic NSCLC cases, affecting an estimated 4,000-5,000 patients in the U.S. annually.

In a clinical study, Tabrecta delivered an overall response rate (ORR) of 68% in patients who had not previously received treatment for NSCLC (treatment-naïve), and a 41% ORR in patients who had undergone prior NSCLC treatment. Patients who received Tabrecta had a median duration of response of 12.6 months if treatment-naive and 9.7 months if previously treated for NSCLC. Recommended dosing is 400mg taken by mouth twice daily with or without food.

Tabrecta has launched at a wholesale acquisition cost (WAC) of $8,975 for 56 tablets. Because Tabrecta received accelerated approval, continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.