FDA Approves First Targeted Therapy to Treat Aggressive Form of Lung Cancer | FDA

FDA Approves First Targeted Therapy to Treat Aggressive Form of Lung Cancer | FDA

FDA Approves First Targeted Therapy to Treat Aggressive Form of Lung Cancer

Today, the U.S. Food and Drug Administration 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. Common side effects for patients taking Tabrecta are peripheral edema (leg swelling), nausea, fatigue, vomiting, dyspnea (shortness of breath) and decreased appetite. Tabrecta may cause serious side effects including interstitial lung disease (a group of lung conditions that causes scarring of lung tissues) or pneumonitis (inflammation of the lung tissue). Tabrecta should be permanently discontinued in patients with these side effects. Tabrecta may also cause hepatotoxicity (damage to liver cells), and health care professionals should monitor a patient’s liver function tests prior to starting and when taking Tabrecta. If a patient experiences hepatotoxicity, Tabrecta should be withheld, dose reduced or permanently discontinued. Based on a clear positive signal for phototoxicity (drug-induced damage to cells that is enhanced by UV light) in laboratory studies in cells, patients may be more sensitive to sunlight and should be advised to take precautions to cover their skin and use sunscreen and not to tan while taking Tabrecta. Tabrecta may cause harm to a developing fetus or newborn baby. Health care professionals should advise pregnant women of this risk and should advise both females of reproductive potential and male patients with female partners of reproductive potential to use effective contraception during treatment with Tabrecta and for one week after the last dose.

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