Amivantamab: Difference between revisions
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Revision as of 02:39, 23 May 2021
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| Trade names | Rybrevant |
| Other names | JNJ-61186372, amivantamab-vmjw |
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| Drug class | Antineoplastic |
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| Formula | C6472H10014N1730O2023S46 |
| Molar mass | 145902.15 g·mol−1 |
Amivantamab, sold under the brand name Rybrevant, is a medication used to treat non-small cell lung cancer.[1][3][4]
The most common side effects include rash, infusion-related reactions, skin infections around the fingernails or toenails, muscle and joint pain, shortness of breath, nausea, fatigue, swelling in the lower legs or hands or face, sores in the mouth, cough, constipation, vomiting and changes in certain blood tests.[1][2]
Amivantamab is a bispecific EGF receptor-directed and MET receptor- directed antibody. It is the first treatment for adults with non-small cell lung cancer whose tumors have specific types of genetic mutations: epidermal growth factor receptor (EGFR) exon 20 insertion mutations.[1]
Medical uses
Amivantamab indicated for the treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.[2]
History
The U.S. Food and Drug Administration (FDA) approved amivantamab based on CHRYSALIS, a multicenter, non-randomized, open label, multicohort clinical trial (NCT02609776) which included participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations.[2] Efficacy was evaluated in 81 participants with advanced NSCLC with EGFR exon 20 insertion mutations whose disease had progressed on or after platinum-based chemotherapy.[2]
The FDA collaborated on the review of amivantamab with the Brazilian Health Regulatory Agency (ANVISA) and the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA).[2] The application reviews are ongoing at the other regulatory agencies.[2]
Society and culture
Names
Amivantamab is the recommended international nonproprietary name (INN),[5]
References
- ^ a b c d "FDA Approves First Targeted Therapy for Subset of Non-Small Cell Lung Cancer". U.S. Food and Drug Administration (FDA) (Press release). 21 May 2021. Retrieved 21 May 2021.
This article incorporates text from this source, which is in the public domain.
- ^ a b c d e f g "FDA grants accelerated approval to amivantamab-vmjw for mNSCLC". U.S. Food and Drug Administration (FDA). 21 May 2021. Retrieved 21 May 2021. This article incorporates text from this source, which is in the public domain.
- ^ "Rybrevant (amivantamab-vmjw) Receives FDA Approval as the First Targeted Treatment for Patients with Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations" (Press release). Janssen. 21 May 2021. Retrieved 21 May 2021 – via PR Newswire.
- ^ "Genmab Announces that Janssen has been Granted U.S. FDA" (Press release). Genmab A/S. 21 May 2021. Retrieved 21 May 2021 – via GlobeNewswire.
- ^ World Health Organization (2020). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83" (PDF). WHO Drug Information. 34 (1).
This article incorporates public domain material from the United States Department of Health and Human Services
Further reading
- Neijssen J, Cardoso RM, Chevalier KM, Wiegman L, Valerius T, Anderson GM, et al. (April 2021). "Discovery of amivantamab (JNJ-61186372), a bispecific antibody targeting EGFR and MET". J Biol Chem: 100641. doi:10.1016/j.jbc.2021.100641. PMC 8113745. PMID 33839159.
- Yun J, Lee SH, Kim SY, Jeong SY, Kim JH, Pyo KH, et al. (August 2020). "Antitumor Activity of Amivantamab (JNJ-61186372), an EGFR-MET Bispecific Antibody, in Diverse Models of EGFR Exon 20 Insertion-Driven NSCLC". Cancer Discov. 10 (8): 1194–1209. doi:10.1158/2159-8290.CD-20-0116. PMID 32414908.
External links
- "Amivantamab". Drug Information Portal. U.S. National Library of Medicine.
- Clinical trial number NCT02609776 for "Study of Amivantamab, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer (CHRYSALIS)" at ClinicalTrials.gov
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