Chemistry:Telisotuzumab vedotin
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| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized |
| Target | c-Met |
| Clinical data | |
| Trade names | Emrelis |
| Other names | ABBV-399, telisotuzumab vedotin-tllv |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a625080 |
| License data | |
| Routes of administration | Intravenous infusion |
| ATC code |
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| Legal status | |
| Legal status | |
| Identifiers | |
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| 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] The US Food and Drug Administration considers it to be a first-in-class medication.[5][6]
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
Legal status
Telisotuzumab vedotin was approved for medical use in the United States in May 2025.[2][3]
Names
Telisotuzumab vedotin is the international nonproprietary name.[7]
Telisotuzumab vedotin is sold under the brand name Emrelis.[2]
References
- ↑ 1.0 1.1 1.2 1.3 "Emrelis- telisotuzumab vedotin injection, powder, lyophilized, for solution". 25 May 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bc04f980-3957-4e35-ab81-8ec2ffe87215.
- ↑ 2.00 2.01 2.02 2.03 2.04 2.05 2.06 2.07 2.08 2.09 2.10 2.11 "FDA grants accelerated approval to telisotuzumab vedotin-tllv for NSCLC with high c-Met protein overexpression". 14 May 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-telisotuzumab-vedotin-tllv-nsclc-high-c-met-protein-overexpression.
This article incorporates text from this source, which is in the public domain.
- ↑ 3.0 3.1 "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.
- ↑ 4.0 4.1 4.2 4.3 4.4 4.5 "Drug Trials Snapshots: Emrelis". 14 May 2025. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-emrelis. This article incorporates text from this source, which is in the public domain.
- ↑ "Novel Drug Approvals for 2025". 8 July 2026. https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025.
- ↑ "Advancing Health Through Innovation: New Drug Therapy Approvals 2025" (PDF). January 2026. https://www.fda.gov/media/190705/download.
- ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 77". WHO Drug Information 31 (1). 2017.
Further reading
- Camidge, D. Ross; Barlesi, Fabrice; Goldman, Jonathan W.; Morgensztern, Daniel; Heist, Rebecca; Vokes, Everett; Spira, Alex; Angevin, Eric et al. (February 2023). "Phase Ib Study of Telisotuzumab Vedotin in Combination With Erlotinib in Patients With c-Met Protein–Expressing Non–Small-Cell Lung Cancer". Journal of Clinical Oncology 41 (5): 1105–1115. doi:10.1200/JCO.22.00739. ISSN 0732-183X. PMID 36288547.
- Camidge, D. Ross; Barlesi, Fabrice; Goldman, Jonathan W.; Morgensztern, Daniel; Heist, Rebecca; Vokes, Everett; Angevin, Eric; Hong, David S. et al. (January 2022). "A Phase 1b Study of Telisotuzumab Vedotin in Combination With Nivolumab in Patients With NSCLC". JTO Clinical and Research Reports 3 (1). doi:10.1016/j.jtocrr.2021.100262. PMID 35005654.
- Fujiwara, Yutaka; Kenmotsu, Hirotsugu; Yamamoto, Noboru; Shimizu, Toshio; Yonemori, Kan; Ocampo, Christopher; Parikh, Apurvasena; Okubo, Sumiko et al. (April 2021). "Phase 1 study of telisotuzumab vedotin in Japanese patients with advanced solid tumors". Cancer Medicine 10 (7): 2350–2358. doi:10.1002/cam4.3815. ISSN 2045-7634. PMID 33675179.
- Strickler, John H.; Weekes, Colin D.; Nemunaitis, John; Ramanathan, Ramesh K.; Heist, Rebecca S.; Morgensztern, Daniel; Angevin, Eric; Bauer, Todd M. et al. (November 2018). "First-in-Human Phase I, Dose-Escalation and -Expansion Study of Telisotuzumab Vedotin, an Antibody–Drug Conjugate Targeting c-Met, in Patients With Advanced Solid Tumors". Journal of Clinical Oncology 36 (33): 3298–3306. doi:10.1200/jco.2018.78.7697. PMID 30285518.
- Waqar, Saiama N.; Redman, Mary W.; Arnold, Susanne M.; Hirsch, Fred R.; Mack, Philip C.; Schwartz, Lawrence H.; Gandara, David R.; Stinchcombe, Thomas E. et al. (May 2021). "A Phase II Study of Telisotuzumab Vedotin in Patients With c–MET-positive Stage IV or Recurrent Squamous Cell Lung Cancer (LUNG-MAP Sub-study S1400K, NCT03574753)". Clinical Lung Cancer 22 (3): 170–177. doi:10.1016/j.cllc.2020.09.013. ISSN 1525-7304. PMID 33221175.
External links
- 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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