Telisotuzumab vedotin

Telisotuzumab vedotin
Monoclonal antibody
TypeWhole antibody
SourceHumanized
Targetc-Met
Clinical data
Trade namesEmrelis
Other namesABBV-399, telisotuzumab vedotin-tllv
AHFS/Drugs.comMonograph
MedlinePlusa625080
Routes of
administration		Intravenous infusion
ATC code
  • None
Legal status
Legal status
Identifiers
UNII
KEGG

Telisotuzumab vedotin, sold under the brand name Emrelis, is an antibody drug conjugate used for the treatement of non-small cell lung cancer.[1][2] Telisotuzumab vedotin is a c-Met-directed antibody and microtubule inhibitor conjugate.[1] It was developed by AbbVie.[3]

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]

The FDA granted the application for telisotuzumab vedotin priority review and breakthrough therapy designations.[2]

Society and culture

Telisotuzumab vedotin was approved for medical use in the United States in May 2025.[2][3]

Names

Telisotuzumab vedotin is the international nonproprietary name.[5]

Telisotuzumab vedotin is sold under the brand name Emrelis.[2]

References

  1. 1 2 3 4 "Emrelis- telisotuzumab vedotin injection, powder, lyophilized, for solution". DailyMed. 25 May 2025. Retrieved 23 August 2025.
  2. 1 2 3 4 5 6 7 8 9 10 11 12 "FDA grants accelerated approval to telisotuzumab vedotin-tllv for NSCLC with high c-Met protein overexpression". U.S. Food and Drug Administration. 14 May 2025. Archived from the original on 16 May 2025. Retrieved 30 May 2025. Public Domain This article incorporates text from this source, which is in the public domain.
  3. 1 2 "U.S. FDA Approves Emrelis (telisotuzumab vedotin-tllv) for Adults With Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC) With High c-Met Protein Overexpression" (Press release). AbbVie. 14 May 2025. Retrieved 30 May 2025 – via PR Newswire.
  4. 1 2 3 4 5 6 "Drug Trials Snapshots: Emrelis". U.S. Food and Drug Administration (FDA). 14 May 2025. Retrieved 23 August 2025. Public Domain This article incorporates text from this source, which is in the public domain.
  5. ↑ World Health Organization (2017). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 77". WHO Drug Information. 31 (1). hdl:10665/330984.

Further reading

  • 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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