THURSDAY, May 7, 2020 (HealthDay News) -- Tabrecta (capmatinib) has received the first approval for the treatment of metastatic non-small cell lung cancer (NSCLC) with specific mutations that lead to mesenchymal-epithelial transition or MET exon 14 skipping, the U.S. Food and Drug Administration announced Wednesday.
Three to 4 percent of patients with lung cancer have mutations leading to MET exon 14 skipping, according to the FDA. The agency also approved the companion diagnostic FoundationOne CDx assay (F1CDx), a next-generation sequencing-based in vitro diagnostic device that detects these mutations.
Approval of Tabrecta, a kinase inhibitor, was based on clinical trial data of patients with NSCLC with mutations that lead to MET exon 14 skipping, epidermal growth factor receptor wild-type- and anaplastic lymphoma kinase-negative status, and at least one measurable lesion. The trial included 28 treatment-naive patients and 69 previously treated patients; all received 400 mg of Tabrecta orally twice daily until disease progression or toxicity. The researchers noted overall response rates of 68 and 41 percent for the treatment-naive and previously treated patients, respectively. Of the 28 previously untreated patients, 4 percent had complete response and 64 percent had a partial response. All of the previously treated patients had a partial response. Forty-seven and 32.1 percent of the treatment-naive and previously treated patients, respectively, had a response duration of one year or longer.
The most commonly reported side effects were peripheral edema, nausea, fatigue, vomiting, dyspnea, and decreased appetite. Potential serious side effects include interstitial lung disease, pneumonitis, and hepatotoxicity. Physicians are advised to monitor patients' liver function tests before and during treatment with Tabrecta.
Approval of Tabrecta was granted to Novartis Pharmaceuticals Corporation. Approval of the F1CDx was granted to Foundation Medicine.