The FDA granted an accelerated approval to capmatinib (Tabrecta) for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) with a mutation that leads to MET exon 14 skipping (METex14), as detected by an FDA-approved test, according to Novartis, the manufacturer of the oral MET inhibitor.
This is the first and only treatment approved by the FDA for this patient population.
The agency also approved FoundationOne®CDx as the companion diagnostic test for the drug.
“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, in a statement. “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 a targeted therapy, offering new hope for patients with NSCLC harboring this type of mutation.”
The approval was based on results from the multicenter, non-randomized, open-label phase II GEOMETRY mono-1 trial, which examined 97 patients with METex14 NSCLC. In this group, the overall response rate (ORR) was 68% in treatment-naïve patients, and 41% in the previously treated patients.
Median duration of response was 12.6 months in the treatment-naïve patients, and 9.7 months in the previously treated patients.
Common adverse events (occurring in at least 20% of patients) that nurses should look out for included: 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 the statement. “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.”
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