The Food and Drug Administration (FDA) has approved Tepmetko (tepotinib) for adult patients with metastatic non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition (MET) exon 14 skipping alterations, the agency has announced.
Tepmetko had received accelerated approval for this patient population in 2021 based on the findings of the VISION trial, with the conversion to traditional approval based on additional patient follow-up time to assess the treatment’s duration of response, the FDA reported.
A total of 313 patients with metastatic NSCLC with MET exon skipping alterations received 450 mg of Tepmetko daily until disease progression or unacceptable toxicity.
The objective response rate (ORR; patients whose disease responded partially or completely to treatment) was 57% among 164 treatment-naïve patients, and 40% of responders had a duration of response (DOR) that a year (12 months) or more. Among 149 patients who were previously treated, the ORR was 45%, and 36% of responders had a DOR of more than a year, according to the agency.
The most common side effects in at least 20% of patients were edema, nausea, fatigue, musculoskeletal pain, diarrhea, dyspnea, decreased appetite and rash, the FDA stated.
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