FDA Grants Tepotinib Accelerated Approval for MET Exon 14-Skipping NSCLC

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The FDA has granted tepotinib (Tepmetko) accelerated approval for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) with MET exon 14-skipping alterations, according to the FDA.

FDA Grants Tepotinib Accelerated Approval for MET Exon 14-Skipping NSCLC

FDA Grants Tepotinib Accelerated Approval for MET Exon 14-Skipping NSCLC

The FDA approved tepotinib (Tepmetko) for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) with MET exon 14-skipping alterations, according to the agency.

The approval is based on findings from the multicenter, non-randomized, open-label multicohort VISION trial (NCT02864992), which involved 152 patients with advanced/metastatic NSCLC with MET exon 14 skipping alterations who were given 450 mg of tepotinib orally once a day until their disease progressed or they faced unacceptable toxicity.

The study involved 69 treatment-naïve patients, and average overall response rate (ORR) was 43%, with a median response duration of 10.8 months in this population. In the 83 previously treated patients, the ORR Was 43% with a median response duration of 11.1 months.

Recommended dosing for tepotinib is 450 mg daily, taken with food. Oncology nurses should encourage their patients to take the drug at the same time each day, and to swallow the tablet whole, not crushing, chewing, or splitting it.

According to the prescribing information, patients should not make up a missed dose within 8 hours of their next scheduled dose.

The most common adverse events from tepotinib, which occurred in 20% or more of patients, were edema, fatigue, nausea, diarrhea, musculoskeletal pain, and dyspnea. Tepotinib can also cause interstitial lung disease, hepatotoxicity, and embryo-fetal toxicity.

If a patient vomits after taking tepotinib, they should take the next dose at the scheduled time. Additionally, if they need a dose modification, the recommended modified dose is 225 mg. Patients who cannot tolerate this dosage should permanently discontinue tepotinib.

This accelerated approval was based on ORR and response duration in the VISION trial. Continued approval may be contingent upon verification and description of clinical benefit seen in future results of confirmatory trials.

References

FDA grants accelerated approval to tepotinib for metastatic non-small cell lung cancer. News release. FDA. February 3, 2021. Accessed February 3, 2021. http://bit.ly/3az71Cj.

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