FDA grants accelerated approval to Tepmetko for metastatic NSCLC

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print

FDA has granted accelerated approval to Tepmetko (tepotinib) for adult patients with metastatic non-small cell lung cancer harboring mesenchymal-epithelial transition exon 14 skipping alterations.

Tepmetko is sponsored by EMD Serono Inc.

Efficacy was demonstrated in the VISION trial (NCT02864992), a multicenter, non-randomized, open-label, multicohort study enrolling 152 patients with advanced or metastatic NSCLC with MET exon 14 skipping alterations. Patients received tepotinib 450 mg orally once daily until disease progression or unacceptable toxicity.

The main efficacy outcome measures were overall response rate determined by a blinded independent review committee using RECIST 1.1 and response duration. Among the 69 treatment naïve patients, the ORR was 43% (95% CI: 32%, 56%) with a median response duration of 10.8 months (95% CI: 6.9, not estimable). Among the 83 previously treated patients, the ORR was 43% (95% CI: 33%, 55%) with a median response duration of 11.1 months (95% CI: 9.5, 18.5).

Table of Contents

YOU MAY BE INTERESTED IN

In the days leading up to the 2021 American Society of Clinical Oncology annual meeting, The Cancer Letter published a piece focused on Axel Grothey’s unethical sexual relationships with women he mentored while at Mayo Clinic. While this news was met by some as shocking, science tells us it is anything but.

Login