Telisotuzumab vedotin
| 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 | Multum Consumer Information |
| Routes of administration | Intravenous infusion |
| ATC code |
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| 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] Telisotuzumab vedotin is a c-Met-directed antibody and microtubule inhibitor conjugate.[1] It was developed by AbbVie.
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][3]
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.[2][3]
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 US Food and Drug Administration (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][4]
References
- ^ a b c https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761384s000lbl.pdf
- ^ a b c d e f g h i j "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. This article incorporates text from this source, which is in the public domain.
- ^ a b "Novel Drug Approvals for 2025". U.S. Food and Drug Administration (FDA). 29 May 2025. Archived from the original on 3 March 2025. Retrieved 29 May 2025. This article incorporates text from this source, which is in the public domain.
- ^ "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.
Further reading
- Camidge, D. Ross; Barlesi, Fabrice; Goldman, Jonathan W.; Morgensztern, Daniel; Heist, Rebecca; Vokes, Everett; et al. (10 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. PMC 9928626. PMID 36288547.
- Camidge, D. Ross; Barlesi, Fabrice; Goldman, Jonathan W.; Morgensztern, Daniel; Heist, Rebecca; Vokes, Everett; 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): 100262. doi:10.1016/j.jtocrr.2021.100262. PMC 8717236. PMID 35005654.
- Fujiwara, Yutaka; Kenmotsu, Hirotsugu; Yamamoto, Noboru; Shimizu, Toshio; Yonemori, Kan; Ocampo, Christopher; 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. PMC 7982615. PMID 33675179.
- Strickler, John H.; Weekes, Colin D.; Nemunaitis, John; Ramanathan, Ramesh K.; Heist, Rebecca S.; Morgensztern, Daniel; et al. (20 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.; et al. (1 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. PMC 8044254. 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