The US Food and Drug Administration (FDA) recently approved a therapeutic for treating metastatic non-small cell lung cancer (NSCLC). The therapeutic called ‘Tabrecta™ (capmatinib, formerly INC280)’ is an oral MET inhibitor for patients with a METex14 mutation in their tumors.
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“Non-small cell lung cancer is a complex disease, with many different possible mutations that may encourage the cancer’s growth,” said Juergen Wolf, MD, from the Center for Integrated Oncology, University Hospital Cologne and lead investigator of the GEOMETRY study. “MET exon 14 skipping is a known oncogenic driver. With today’s decision by the FDA, we can now test for and treat this challenging form of lung cancer with targeted therapy, offering new hope for patients with NSCLC harboring this type of mutation.”
The approval of Trabecta is based on findings from the pivotal GEOMETRY mono-1 Phase II clinical trial. The most common side-effects noted were peripheral edema, nausea, fatigue, vomiting, dyspnea, and decreased appetite.
“Today, and especially during these difficult times, we are incredibly proud that Tabrecta is the first treatment approved by the FDA specifically to treat patients diagnosed with this aggressive NSCLC associated with METex14,” said Susanne Schaffert, PhD, President, Novartis Oncology. “In our quest to reimagine medicine, we have worked tirelessly over the past decades to advance the understanding and treatment of NSCLC, striving to make a difference in patients’ lives, one mutation at a time. We thank all the physicians, patients and families involved in the Tabrecta clinical trials, and we remain committed to advancing innovative solutions for the patients we work to serve.”