The most common adverse reactions include peripheral neuropathy, fatigue, decreased appetite, and peripheral edema.[2] The most common grade 3 or 4 laboratory abnormalities include decreased lymphocytes, increased glucose, increased alanine aminotransferase, increased gamma glutamyl transferase, decreased phosphorus, decreased sodium, decreased hemoglobin, and decreased calcium.[2]
Telisotuzumab vedotin was approved for medical use in the United States in May 2025.[2][4]
Medical uses
Telisotuzumab vedotin is indicated for the treatment of adults with locally advanced or metastatic non-squamous non-small cell lung cancer with high c-Met protein overexpression who have received a prior systemic therapy.[1][2][4]
Adverse effects
The most common adverse reactions include peripheral neuropathy, fatigue, decreased appetite, and peripheral edema.[2] The most common grade 3 or 4 laboratory abnormalities include decreased lymphocytes, increased glucose, increased alanine aminotransferase, increased gamma glutamyl transferase, decreased phosphorus, decreased sodium, decreased hemoglobin, and decreased calcium.[2]
History
Efficacy was evaluated in the LUMINOSITY study (NCT03539536), a multi-center, open label, multi-cohort trial.[2] The trial included 84 participants with epidermal growth factor receptor wild-type, non-squamous non-small cell lung cancer with high c-Met protein overexpression who had received prior systemic therapy.[2] The benefits and side effects of telisotuzumab vedotin were evaluated in one clinical trial of 168 participants with non-squamous, EGFR wild-type non-small cell lung cancer with high c-Met protein overexpression who had received one to three prior systemic treatments.[4] The US Food and Drug Administration (FDA) granted accelerated approval to telisotuzumab vedotin based predominantly on evidence from one clinical trial (LUMINOSITY/NCT03539536) of 168 participants with non-squamous, epidermal growth factor receptor (EGFR) wild-type non-small cell lung cancer with c Met protein overexpression who had received prior systemic therapy, including 19 participants from the United States.[4] The trial was conducted at 119 sites across 23 countries in North America, Europe, Asia, the Middle East, and Oceania.[4] There were 84 participants with non-squamous, EGFR wild-type non-small cell lung cancer with high c-Met protein overexpression who had received prior systemic therapy.[4]
↑ World Health Organization (2017). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 77". WHO Drug Information. 31 (1). hdl:10665/330984.
Clinical trial number NCT03539536 for "Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer" at ClinicalTrials.gov
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