Introduction and marketing status of Telisotuzumab vedotin

On May 14, 2025, the U.S. Food and Drug Administration (FDA) accelerated the approval of Telisotuzumab vedotin), an antibody-drug conjugate (ADC) targeting the c-Met protein that combines an antibody and a microtubule inhibitor. The drug is mainly used to treat patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose overexpression of c-Met protein in tumor cells reaches or exceeds 50% and who have previously received systemic therapy. FDA also approved VENTANA MET (SP44) RxDx an auxiliary diagnostic test to help screen patients eligible for treatment and improve the accuracy of treatment.

The efficacy of Emrelis was evaluated in a multicenter, open-label photometric study (NCT03539536). The study included 84 patients with epidermal growth factor receptor (EGFR) wild-type and c-Met high expression of non-squamous non-small cell lung cancer, all of whom had received systemic treatment. The primary efficacy endpoints were overall response rate (ORR) and duration of response (DOR) determined by blinded independent central review (BICR) according to RECIST 1.1 criteria. The results of the study showed that the ORR reached 35% and the median response duration was 7.2 months, showing good anti-tumor activity.

In terms of security,EmrelisCommon adverse reactions include peripheral neuropathy, fatigue, decreased appetite and peripheral edema, with incidence rates exceeding 20%. More serious laboratory abnormalities of Grade 3 or Grade 4 include lymphopenia, increased blood sugar, abnormal liver function indicators (such as increased alanine aminotransferase and gamma glutamyl transferase), electrolyte disorders (decreased phosphorus, sodium, and calcium), and decreased hemoglobin. These adverse reactions require close monitoring during treatment.

Regarding dosage, telisotuzumab vedotin-tllvrecommended dose is 1.9 mg/kg (the maximum dose for patients weighing more than 100kg is 190 mg) by intravenous infusion every two weeks until disease progression or unacceptable toxicity. With the approval of FDA, Emrelis is expected to become an important targeted drug for the treatment of patients with non-squamous non-small cell lung cancer with high expression of c-Met, providing new treatment options for these patients.

Reference materials:https://www.fda.gov/drugs/resources-information-approved-drugs