Oncology Drug Reference Sheet: Capmatinib

In August 2022, the U.S. Food and Drug Administration granted regular approval to capmatinib (Tabrecta®) for adults with metastatic non-small cell lung cancer whose tumors have a variant that leads to mesenchymal-epithelial transition exon 14 skipping. Capmatinib was granted accelerated approval for the same indication in May 2020; the regular approval in August 2022 was based on additional data from 63 patients and follow-up data establishing durability of response and clinical benefit.