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Amivantamab

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Amivantamab
Space-filling model of the anti-MET arm of amivantamab (blue) bound to the Sema domain of human MET (puce). PDB: 6wvz​
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetEpidermal growth factor receptor (EGFR) and Mesenchymal–epithelial transition (MET)
Clinical data
Trade namesRybrevant
Other namesJNJ-61186372, amivantamab-vmjw
AHFS/Drugs.comMonograph
MedlinePlusa621034
License data
Pregnancy
category
Routes of
administration		Intravenous infusion
Drug classAntineoplastic
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
UNII
KEGG
Chemical and physical data
FormulaC6472H10014N1730O2023S46
Molar mass145902.15 g·mol−1

Amivantamab, sold under the brand name Rybrevant, is a bispecific monoclonal antibody used to treat non-small cell lung cancer.[4][5][6][7] Amivantamab is a bispecific epidermal growth factor (EGF) receptor-directed and mesenchymal–epithelial transition (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.[5]

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.[5][6]

Amivantamab was approved for medical use in the United States in May 2021,[5][6][8][9] and in the European Union in December 2021.[7] The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[10]

Medical uses

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Amivantamab is indicated for the treatment of adults with locally advanced or metastatic non-small cell lung cancer 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.[6]

In March 2024, the FDA approved amivantamab, in combination with carboplatin and pemetrexed, for the first-line treatment of locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test.[11] The FDA also granted traditional approval to amivantamab for adults with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.[11] The FDA previously granted accelerated approval for this indication.[11] The expanded indication for amivantamab was approved in the European Union in July 2024.[12]

In August 2024, the FDA approved lazertinib, in combination with amivantamab, for the treatment of non-small lung cancer.[13]

In September 2024, the FDA approved amivantamab-vmjw with carboplatin and pemetrexed for adults with locally advanced or metastatic non-small-cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.[14]

Side effects

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The most common side effects include rash, infusion-related reactions, infected skin around the nail, muscle and joint pain, shortness of breath, nausea, feeling very tired, swelling of hands, ankles, feet, face, or all of your body, sores in the mouth, cough, constipation, vomiting, and changes in certain blood tests (for example, decreased albumin levels, increased glucose levels, increased liver enzymes).[15]

Amivantamab may cause serious side effects including infusion-related reactions, lung inflammation, skin problems, eye problems, and harm to an unborn baby.[15]

History

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The US 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.[6] 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.[6] In the published study, the overall response rate was 40%, with a median duration of response of 11.1 months, and a median progression-free survival of 8.3 months (95% CI, 6.5 to 10.9).[16] The trial was conducted at 53 sites in the United States, South Korea, Taiwan, Japan, Great Britain, France, Spain, Canada, China, and Australia.[15]

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).[6] The application reviews are ongoing at the other regulatory agencies.[6]

In March 2024, the FDA approved amivantamab, in combination with carboplatin and pemetrexed, for the first-line treatment of locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test.[11] The FDA also granted traditional approval to amivantamab for adults with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.[11] The FDA previously granted accelerated approval for this indication.[11] Efficacy was evaluated in PAPILLON (NCT04538664), a randomized, open-label multicenter trial of 308 participants with epidermal growth factor receptor (EGFR) exon 20 insertion mutations.[11] Participants were randomized 1:1 to receive amivantamab with carboplatin and pemetrexed or carboplatin and pemetrexed.[11]

Society and culture

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Amivantamab was approved for medical use in the United States in May 2021.[5][6][8][9]

In October 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a conditional marketing authorization for the medicinal product Rybrevant, intended for the treatment of non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations.[17] The applicant for this medicinal product was Janssen-Cilag International N.V.[17] Amivantamab was approved for medical use in the European Union in December 2021.[7][18] The conditional conditional marketing authorization was converted to a standard marketing authorization in July 2024.[12][19]

Names

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Amivantamab is the international nonproprietary name (INN).[20]

Research

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Amivantamab is being investigated in combination with lazertinib versus osimertinib; and in combination with carboplatin-pemetrexed chemotherapy compared to carboplatin-pemetrexed.[21][22]

References

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  1. ^ a b "Rybrevant (Janssen-Cilag Pty Ltd)". Therapeutic Goods Administration (TGA). 13 January 2023. Archived from the original on 27 March 2023. Retrieved 18 April 2023.
  2. ^ "Rybrevant Product information". Health Canada. 25 April 2012. Archived from the original on 29 June 2022. Retrieved 29 June 2022.
  3. ^ "Summary Basis of Decision - Rybrevant". Health Canada. 23 October 2014. Archived from the original on 6 August 2022. Retrieved 6 August 2022.
  4. ^ a b "Rybrevant- amivantamab injection". DailyMed. Janssen Pharmaceutical Companies. Archived from the original on 26 May 2021. Retrieved 25 May 2021.
  5. ^ a b c d e f "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. Archived from the original on 21 May 2021. Retrieved 21 May 2021. Public Domain This article incorporates text from this source, which is in the public domain.
  6. ^ a b c d e f g h i j "FDA grants accelerated approval to amivantamab-vmjw for mNSCLC". U.S. Food and Drug Administration (FDA). 21 May 2021. Archived from the original on 22 May 2021. Retrieved 21 May 2021. Public Domain This article incorporates text from this source, which is in the public domain.
  7. ^ a b c d "Rybrevant EPAR". European Medicines Agency (EMA). 12 October 2021. Archived from the original on 23 April 2022. Retrieved 23 April 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  8. ^ a b "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 Pharmaceutical Companies. 21 May 2021. Archived from the original on 21 May 2021. Retrieved 21 May 2021 – via PR Newswire.
  9. ^ a b "Genmab Announces that Janssen has been Granted U.S. FDA" (Press release). Genmab A/S. 21 May 2021. Archived from the original on 21 May 2021. Retrieved 21 May 2021 – via GlobeNewswire.
  10. ^ Advancing Health Through Innovation: New Drug Therapy Approvals 2021 (PDF). U.S. Food and Drug Administration (FDA) (Report). 13 May 2022. Archived from the original on 6 December 2022. Retrieved 22 January 2023. Public Domain This article incorporates text from this source, which is in the public domain.
  11. ^ a b c d e f g h "FDA approves amivantamab-vmjw for EGFR exon 20 insertion-mutated non-small cell lung cancer indications". U.S. Food and Drug Administration (FDA). 1 March 2024. Archived from the original on 9 March 2024. Retrieved 9 March 2024. Public Domain This article incorporates text from this source, which is in the public domain.
  12. ^ a b "Rybrevant (amivantamab) in combination with chemotherapy is the first therapy approved by the European Commission for the first-line treatment of people with advanced non-small cell lung cancer with activating EGFR exon 20 insertion mutations". Janssen (Press release). Archived from the original on 3 July 2024. Retrieved 2 July 2024.
  13. ^ "FDA approves lazertinib with amivantamab-vmjw for non-small lung cancer". U.S. Food and Drug Administration (FDA). 19 August 2024. Retrieved 21 August 2024.
  14. ^ "FDA approves amivantamab-vmjw with carboplatin and pemetrexed for non-small cell lung cancer with EGFR exon 19 deletions or L858R mutations". U.S. Food and Drug Administration (FDA). 19 September 2024. Retrieved 20 September 2024. Public Domain This article incorporates text from this source, which is in the public domain.
  15. ^ a b c "Drug Trials Snapshot: Rybrevant". U.S. Food and Drug Administration (FDA). 9 May 2023. Archived from the original on 10 May 2023. Retrieved 9 May 2023. Public Domain This article incorporates text from this source, which is in the public domain.
  16. ^ Park K, Haura EB, Leighl NB, Mitchell P, Shu CA, Girard N, et al. (October 2021). "Amivantamab in EGFR Exon 20 Insertion-Mutated Non-Small-Cell Lung Cancer Progressing on Platinum Chemotherapy: Initial Results From the CHRYSALIS Phase I Study". Journal of Clinical Oncology. 39 (30): 3391–3402. doi:10.1200/JCO.21.00662. PMC 8791812. PMID 34339292.
  17. ^ a b "Rybrevant: Pending EC decision". European Medicines Agency. 15 October 2021. Archived from the original on 15 October 2021. Retrieved 15 October 2021. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  18. ^ "Rybrevant Product information". Union Register of medicinal products. Archived from the original on 4 March 2023. Retrieved 3 March 2023.
  19. ^ "Rybrevant (amivantamab) in combination with chemotherapy is the first therapy approved by the European Commission for the first-line treatment of patients with advanced non-small cell lung cancer with activating EGFR exon 20 insertion mutations" (Press release). Janssen Cilag International NV. 28 June 2024. Archived from the original on 3 July 2024. Retrieved 3 July 2024 – via GlobeNewswire.
  20. ^ World Health Organization (2020). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83". WHO Drug Information. 34 (1). hdl:10665/339768.
  21. ^ Kaplon H, Reichert JM (2021). "Antibodies to watch in 2021". mAbs. 13 (1): 1860476. doi:10.1080/19420862.2020.1860476. PMC 7833761. PMID 33459118.
  22. ^ "Updated Amivantamab and Lazertinib Combination Data Demonstrate Durable Responses and Clinical Activity for Osimertinib-Relapsed Patients with EGFR-Mutated Non-Small Cell Lung Cancer" (Press release). Janssen Pharmaceutical Companies. 20 May 2021. Archived from the original on 22 May 2021. Retrieved 23 May 2021 – via Business Wire.

Public Domain This article incorporates public domain material from the United States Department of Health and Human Services

Further reading

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  • 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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