Tepotinib is approved by the USFDA for metastatic non-small cell lung cancer

Tepotinib is approved by the USFDA for metastatic, non-small cell lung cancer

Share This Post

The Food and Drug Administration officially approved tepotinib (Tepmetko, EMD Serono, Inc.) on February 15, 2024, for adult patients with metastatic non-small cell lung cancer (NSCLC) that had mesenchymal-epithelial transition (MET) exon 14 skipping mutations.

Tepotinib received accelerated clearance for this use on February 3, 2021, after showing positive results in the VISION trial (NCT02864992), which was a multicenter, non-randomized, open-label, multicohort research. The transition to conventional approval was made after including 161 more patients and extending the follow-up period by 28 months to evaluate the duration of response.

Effectiveness was proven in 313 individuals with metastatic non-small cell lung cancer (NSCLC) carrying MET exon skipping mutations. Patients were administered a daily dose of 450 mg of tepotinib until disease progression or unacceptable toxicity occurred.

The main effectiveness criteria were Objective Response Rate (ORR) and Duration of Response (DOR), assessed by a Blinded Independent Review Committee. Out of 164 patients who had not had treatment before, the Objective Response Rate (ORR) was 57% with a 95% Confidence Interval (CI) of 49 to 65. Among the responders, 40% had a Duration of Response (DOR) of 12 months or more. Out of 149 patients who had received treatment before, the Objective Response Rate (ORR) was 45% with a 95% Confidence Interval (CI) of 37 to 53. Additionally, 36% of the responders had a Duration of Response (DOR) of 12 months or more.

The predominant adverse effects (≥20%) included edema, nausea, exhaustion, musculoskeletal pain, diarrhea, dyspnea, decreased appetite, and rash.

The suggested dose of tepotinib is 450 mg taken orally once a day with meals.

View full prescribing information for Tepmetko.

Subscribe To Our Newsletter

Get updates and never miss a blog from Cancerfax

More To Explore

Repotrectinib has received accelerated approval for adult and pediatric patients with NTRK gene fusion-positive solid tumors
Cancer

Repotrectinib has received accelerated approval for adult and pediatric patients with NTRK gene fusion-positive solid tumors

Repotrectinib has received accelerated approval for treating adult and pediatric patients with NTRK gene fusion-positive solid tumors. This approval, based on promising clinical trial results, provides a new therapeutic option for individuals with this specific genetic alteration, offering hope for improved outcomes. The decision underscores the potential of targeted therapies in addressing rare and difficult-to-treat cancers, emphasizing precision medicine’s role in modern oncology.

Need help? Our team is ready to assist you.

We wish a speedy recovery of your dear and near one.

Start chat
We Are Online! Chat With Us!
Scan the code
Hello,

Welcome to CancerFax !

CancerFax is a pioneering platform dedicated to connecting individuals facing advanced-stage cancer with groundbreaking cell therapies like CAR T-Cell therapy, TIL therapy, and clinical trials worldwide.

Let us know what we can do for you.

1) Cancer treatment abroad?
2) CAR T-Cell therapy
3) Cancer vaccine
4) Online video consultation
5) Proton therapy