FDA Grants Priority Review to Tepotinib for METex14-Altered Metastatic NSCLC
The FDA has granted a priority review designation to new drug application (NDA) for tepotinib as a treatment for patient with metastatic non–small cell lung cancer (NSCLC) whose tumors harbor a MET exon 14 (METex14) skipping mutation identified via an FDA-approved test.1
The NDA is based on data from the phase 2 VISION study (NCT02864992), which showed that the oral, highly selective MET inhibitor elicited an objective response rate (ORR) of 46.5% per independent review committee (IRC) assessment (95% CI, 36.4%-56.8%), a median duration of response (DOR) of 11.1 months (95% CI, 7.2–not estimable [NE]) and a disease control rate (DCR) of 65.7% (95% CI, 55.4%-74.9%).2
“METex14 skipping alterations drive a particularly aggressive form of NSCLC in a patient population that is generally elderly, facing poor clinical prognosis and in urgent need of new therapeutic options,” Luciano Rossetti, Global Head of Research & Development for the Biopharma business of Merck KGaA, stated in a press release. “With this acceptance and review under the Real-Time Oncology Review program, we look forward to working with the FDA and to making this precision medicine available to patients in the United States as soon as possible.” Read more.