On May 6, 2020, the FDA approved Tabrecta (capmatinib; from Novartis), an oral kinase inhibitor, for adults with metastatic (spreading) non–small-cell lung cancer (NSCLC).
To be able to receive Tabrecta, patients must be tested to identify this biomarker (or mutation). Therefore, on the same day, the FDA also approved the Foundation
One CDx assay as a diagnostic test for Tabrecta.
“Tabrecta is the first approval specifically for the treatment of patients with non–small-cell lung cancer whose tumors have mutations that lead to MET exon 14 skipping. This patient population now has an option for a targeted therapy,” said Richard Pazdur, M.D., Director of the FDA’s Oncology Center of Excellence.
The clinical trial that led to the approval of Tabrecta included patients with NSCLC and the MET biomarker; patients were not included if they had EGFR or ALK gene mutations.
Among the 28 patients who had never received treatment for NSCLC, the overall response was 68%, including 4% complete responses and 64% partial responses. Among the 69 patients who received previous therapy, 41% had a partial response to Tabrecta. Moreover, 47% of the patients who received Tabrecta as first treatment versus 32.1% of patients who had previously received other NSCLC therapy responded to Tabrecta.
The most common side effects with Tabrecta were rash, nausea, fatigue, vomiting, shortness of breath, and reduced appetite. The serious side effects included interstitial lung disease or pneumonitis.
