FDA Grants Accelerated Approval to Tabrecta (capmatinib) for Metastatic Non-small Cell Lung Cancer with a Change in MET
May 7, 2020
On May 6th, 2020, the Food and Drug Administration (FDA) approved Tabrecta (capmatinib) for treatment of advanced non-small cell lung cancer (NSCLC) with a change in MET. The FDA based their approval on the results of the clinical trial GEOMETRY mono-1 which showed that more patients receiving Tabrecta experienced a response to the treatment than those on chemotherapy alone. In addition, the response lasted for a longer time.Tabrecta is the first drug approved by the FDA to treat patients whose cancer has the unique MET exon-14 skipping mutation. In addition to the approval for this novel treatment, the FDA has approved the next generation sequencing technology, FoundationOne CDx, as the official companion diagnostic for Tabrecta.