Published on: May 14, 2025
Today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for EMRELIS™ (telisotuzumab vedotin-tllv) to treat adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who exhibit high c-Met protein overexpression and have previously received systemic therapy. High c-Met overexpression is defined as ≥50% of tumor cells with strong (3+) staining, as measured by an FDA-approved test.
This approval is based on overall response rate (ORR) and duration of response (DOR). Continued approval may depend on confirmation and further description of clinical benefit in ongoing confirmatory trials. EMRELIS is a c-Met-directed antibody-drug conjugate (ADC) and the first and only approved therapy for this specific patient population. ADCs are engineered to target unique biomarkers, such as c-Met, delivering a powerful cytotoxic payload directly to the cancer cells expressing the marker.
NSCLC accounts for approximately 85% of all lung cancers, and despite recent treatment advances, lung cancer remains the deadliest form of cancer globally. The c-Met protein is overexpressed in roughly 25% of patients with advanced EGFR wild-type, non-squamous NSCLC and is linked to a poor prognosis. Of these, about half exhibit high c-Met overexpression.
We’ve seen a significant shift in oncology toward biomarker-driven therapies, improving treatment precision and outcomes, said Dr. Jonathan Goldman, professor of medicine and director of thoracic oncology clinical trials at UCLA. Patients with c-Met overexpressing NSCLC often have poor prognoses and few options. EMRELIS, a first-in-class ADC, addresses a vital unmet need in this population.
EMRELIS represents a major milestone as AbbVie’s first internally developed solid tumor therapy and our initial FDA approval for lung cancer, said Dr. Roopal Thakkar, executive vice president of research and development and chief scientific officer at AbbVie. This reflects our dedication to delivering targeted cancer treatments that improve patient outcomes, supported by cutting-edge technology and data science. We’re expanding our ADC portfolio to reach more patients facing hard-to-treat tumors.
Despite advancements in lung cancer therapy, new options are still needed for patients whose treatments have stopped working, said Dr. Upal Basu Roy, executive director of research at LUNGevity Foundation. This approval offers a much-needed targeted therapy for those with high c-Met overexpressing late-stage NSCLC, a group with limited innovation in recent years.
The FDA’s accelerated approval of EMRELIS is supported by results from the Phase 2 LUMINOSITY trial (NCT03539536), which evaluated the safety and efficacy of EMRELIS in patients with advanced NSCLC and c-Met overexpression. In patients with high c-Met protein overexpression (n=84), the study reported an ORR of 35% (95% CI: 24, 46) and a median DOR of 7.2 months (95% CI: 4.2, 12). Common side effects (≥20%) included peripheral neuropathy, fatigue, decreased appetite, and peripheral edema. Grade 3 or 4 lab abnormalities (≥2%) included decreased lymphocytes, increased glucose, elevated liver enzymes, and changes in electrolyte levels.
EMRELIS received Breakthrough Therapy Designation from the FDA in December 2021 based on LUMINOSITY study data.
The therapy is currently being studied as a monotherapy in a global Phase 3 confirmatory trial—TeliMET NSCLC-01—for previously treated patients with high c-Met overexpressing NSCLC. The trial is actively enrolling at clinical sites worldwide. More details are available at www.clinicaltrials.gov.
Additionally, the FDA has approved the Roche VENTANA® MET (SP44) RxDx Assay, the only IHC companion diagnostic for identifying patients eligible for EMRELIS treatment. Testing for c-Met protein expression can be conducted using recent or archived tumor tissue.
Back to News
Empowering Innovation Through Global Conferences and Events.
© 2025 SciInov. All Rights Reserved.