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FDA OKs New Drug for Lung Cancer With c-Met Overexpression
- The FDA granted accelerated approval on May 28, 2025, to AbbVie's telisotuzumab vedotin-tllv for adults with advanced non-squamous NSCLC and high c-Met protein overexpression after prior systemic therapy.
- This approval is based on findings from the phase 2 LUMINOSITY study, which included 84 patients whose tumors showed strong c-Met expression in at least half of the cells as determined by Roche’s FDA-cleared companion diagnostic assay.
- The trial demonstrated a 35% response rate among patients, with the typical length of response lasting approximately 7.2 months. Frequently observed side effects were peripheral neuropathy, fatigue, loss of appetite, and swelling in the extremities.
- Jonathan Goldman emphasized that telisotuzumab vedotin, a pioneering antibody-drug conjugate, offers a promising new treatment option for patients with c-MET overexpressing NSCLC, who currently face poor outcomes and limited therapies.
- AbbVie is expanding its ADC portfolio to provide targeted therapies for difficult tumors, with continued approval for Emrelis depending on confirmatory phase 3 trial results currently in enrollment.
13 Articles
13 Articles
MedPage Today
Anti-Aging, Acupuncture and Health NewsFDA OKs New Drug for Lung Cancer With c-Met Overexpression
(MedPage Today) -- The FDA granted accelerated approval to telisotuzumab vedotin (Emrelis) for the treatment of adults with previously treated, locally advanced, or metastatic non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein...
In Brief for May 28, 2025 - ILCN.org (ILCN/WCLC)
Following its Breakthrough Therapy Designation in December 2021, telisotuzumab vedotin-tllv has cleared another major regulatory hurdle and received accelerated approval from the US Food and Drug Administration (FDA) in May 2025. The approval makes telisotuzumab vedotin-tllv the first therapy approved for previously treated advanced non-small cell lung cancer (NSCLC) with high c-Met expression. The decision is based on findings from the LUMINOSI…
FDA Approves Emrelis (telisotuzumab vedotin-tllv) for High c-MET Expressing NSCLC - GO2 for Lung Cancer
×Did you know? There are different kinds of changes, called mutations, that can happen in the MET gene. These changes can help cancer grow and spread. One type is called c-MET overexpression. This means the cancer cells make too much of a protein called c-MET. On May 14, 2025, the U.S. Food and Drug Administration (FDA) announced accelerated approval of Emrelis (telisotuzumab vedotin-tllv) for people with locally advanced or metastatic, non-squa…
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