Approved First Targeted Therapy to Treat Aggressive Form of Lung Cancer

08 May 2020

GMP News

The U.S. Food and Drug Administration (FDA) approved Tabrecta (capmatinib) for the treatment of adult patients with non-small cell lung cancer (NSCLC) that has spread to other parts of the body. Tabrecta is the first FDA-approved therapy to treat NSCLC with specific mutations (those that lead to mesenchymal-epithelial transition or MET exon 14 skipping).

The FDA also approved the FoundationOne CDx assay (F1CDx) as a companion diagnostic for Tabrecta today. Most patients had tumor samples that were tested for mutations that lead to MET exon 14 skipping using local tests and confirmed with the F1CDx, which is a next-generation sequencing based in vitro diagnostic device that is capable of detecting several mutations, including mutations that lead to MET exon 14 skipping.

NSCLC is a disease in which malignant cancer cells form in the tissues of the lung. It is the most common type of lung cancer with up to 90% of all lung carcinomas falling into the non-small cell category. Mutations leading to MET exon 14 skipping are found in 3-4% of patients with lung cancer.

Tabrecta is a kinase inhibitor, meaning it functions by blocking a key enzyme that results in helping to stop the tumor cells from growing.

Tabrecta was approved under the Accelerated Approval pathway, which provides for the approval of drugs that treat serious or life-threatening diseases and generally provide a meaningful advantage over existing treatments.

The FDA granted approval of Tabrecta to Novartis Pharmaceuticals Corporation. The approval of the F1CDx companion diagnostic was granted to Foundation Medicine, Inc.

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