FDA Approves First Targeted Therapy to Treat Aggressive Form
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U.S. Food and Drug Administration approved Tabrecta (capmatinib) for the treatment of adult patients with non-small cell lung cancer (NSCLC) with specific mutations (those that lead to mesenchymal-epithelial transition or MET exon 14 skipping) that has spread to other parts of the body.

The FDA also approved the FoundationOne CDx assay (F1CDx) as a companion diagnostic for Tabrecta.

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.

The FDA approved Tabrecta based on the results of a clinical trial involving patients with NSCLC with mutations that lead to MET exon 14 skipping, epidermal growth factor receptor (EGFR) wild-type and anaplastic lymphoma kinase (ALK) negative status, and at least one measurable lesion.

Common side effects for patients taking Tabrecta are peripheral edema (leg swelling), nausea, fatigue, vomiting, dyspnea (shortness of breath) and decreased appetite. Serious side effects include interstitial lung disease (a group of lung conditions that causes scarring of lung tissues) or pneumonitis (inflammation of the lung tissue).

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

Source: https://www.fda.gov/news-events/press-announcements/fda-approves-first-targeted-therapy-treat-aggressive-form-lung-cancer
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