Amivantamab Explained

Type:mab
Mab Type:mab
Source:u
Target:Epidermal growth factor receptor (EGFR) and Mesenchymal–epithelial transition (MET)
Tradename:Rybrevant
Dailymedid:Amivantamab
Pregnancy Au:D
Routes Of Administration:Intravenous infusion
Class:Antineoplastic
Atc Prefix:L01
Atc Suffix:FX18
Legal Au:S4
Legal Au Comment:[1]
Legal Ca:Rx-only
Legal Ca Comment:/ Schedule D[2] [3]
Legal Us:Rx-only
Legal Us Comment:[4] [5]
Legal Eu:Rx-only
Cas Number:2171511-58-1
Drugbank:DB16695
Unii:0JSR7Z0NB6
Kegg:D11894
Synonyms:JNJ-61186372, amivantamab-vmjw
C:6472
H:10014
N:1730
O:2023
S:46

Amivantamab, sold under the brand name Rybrevant, is a bispecific monoclonal antibody used to treat non-small cell lung cancer. 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.

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.

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

Medical uses

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.

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. 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. The FDA previously granted accelerated approval for this indication.[9] The expanded indicaton for amivantamab was approved in the European Union in July 2024.[10]

In August 2024, the FDA approved lazertinib, in combination with amivantamab, for the treatment of non-small lung cancer.[11]

Side effects

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).

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

History

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. 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.[12] 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).[13] The trial was conducted at 53 sites in the United States, South Korea, Taiwan, Japan, Great Britain, France, Spain, Canada, China, and Australia.[14]

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

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. 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. The FDA previously granted accelerated approval for this indication. 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. Participants were randomized 1:1 to receive amivantamab with carboplatin and pemetrexed or carboplatin and pemetrexed.

Society and culture

Legal status

Amivantamab was approved for medical use in the United States in May 2021.

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. The applicant for this medicinal product was Janssen-Cilag International N.V.[15] Amivantamab was approved for medical use in the European Union in December 2021.[16] [17] The conditional conditional marketing authorization was converted to a standard marketing authorization in July 2024.[18]

Names

Amivantamab is the international nonproprietary name (INN).[19]

Research

Amivantamab is being investigated in combination with lazertinib versus osimertinib; and in combination with carboplatin-pemetrexed chemotherapy compared to carboplatin-pemetrexed.[20] [21]

Further reading

Notes and References

  1. Web site: Rybrevant (Janssen-Cilag Pty Ltd) . Therapeutic Goods Administration (TGA) . 13 January 2023 . 18 April 2023 . 27 March 2023 . https://web.archive.org/web/20230327062403/https://www.tga.gov.au/resources/prescription-medicines-registrations/rybrevant-janssen-cilag-pty-ltd . live .
  2. Web site: Rybrevant Product information . Health Canada . 25 April 2012 . 29 June 2022 . 29 June 2022 . https://web.archive.org/web/20220629032044/https://health-products.canada.ca/dpd-bdpp/info.do?lang=en&code=101529 . live .
  3. Web site: Summary Basis of Decision - Rybrevant . Health Canada . 23 October 2014 . 6 August 2022 . 6 August 2022 . https://web.archive.org/web/20220806061846/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00594&lang=en . live .
  4. Web site: Rybrevant- amivantamab injection . DailyMed . 25 May 2021 . Janssen Pharmaceutical Companies . 26 May 2021 . https://web.archive.org/web/20210526045213/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1466c070-9f97-4fa4-a955-6a6b59981fb8 . live .
  5. FDA Approves First Targeted Therapy for Subset of Non-Small Cell Lung Cancer . U.S. Food and Drug Administration (FDA) . 21 May 2021 . 21 May 2021 . 21 May 2021 . https://web.archive.org/web/20210521202429/https://www.fda.gov/news-events/press-announcements/fda-approves-first-targeted-therapy-subset-non-small-cell-lung-cancer . live .
  6. 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 . Janssen Pharmaceutical Companies . PR Newswire . 21 May 2021 . 21 May 2021 . 21 May 2021 . https://web.archive.org/web/20210521192145/https://www.prnewswire.com/news-releases/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-301297080.html . live .
  7. Genmab Announces that Janssen has been Granted U.S. FDA . Genmab A/S . GlobeNewswire . 21 May 2021 . 21 May 2021 . 21 May 2021 . https://web.archive.org/web/20210521195240/https://www.globenewswire.com/news-release/2021/05/21/2234313/0/en/Genmab-Announces-that-Janssen-has-been-Granted-U-S-FDA-Approval-for-RYBREVANT-amivantamab-vmjw-for-Patients-with-Metastatic-Non-small-Cell-Lung-Cancer-with-Epidermal-Growth-Factor-.html . live .
  8. Advancing Health Through Innovation: New Drug Therapy Approvals 2021 . U.S. Food and Drug Administration (FDA) . 13 May 2022 . PDF . 22 January 2023 . 6 December 2022 . https://web.archive.org/web/20221206210020/https://www.fda.gov/media/155227/download . live .
  9. Web site: 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 . 9 March 2024 . 9 March 2024 . https://web.archive.org/web/20240309040003/https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-vmjw-egfr-exon-20-insertion-mutated-non-small-cell-lung-cancer-indications . live .
  10. 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 . 2024-07-02 . Janssen . 3 July 2024 . https://web.archive.org/web/20240703043004/https://www.janssen.com/rybrevantrv-amivantamab-combination-chemotherapy-first-therapy-approved-european-commission-first . live .
  11. Web site: FDA approves lazertinib with amivantamab-vmjw for non-small lung cancer . U.S. Food and Drug Administration (FDA) . 19 August 2024 . 21 August 2024.
  12. Web site: FDA grants accelerated approval to amivantamab-vmjw for mNSCLC . U.S. Food and Drug Administration (FDA) . 21 May 2021 . 21 May 2021 . 22 May 2021 . https://web.archive.org/web/20210522002407/https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-amivantamab-vmjw-metastatic-non-small-cell-lung-cancer . live .
  13. Park K, Haura EB, Leighl NB, Mitchell P, Shu CA, Girard N, Viteri S, Han JY, Kim SW, Lee CK, Sabari JK, Spira AI, Yang TY, Kim DW, Lee KH, Sanborn RE, Trigo J, Goto K, Lee JS, Yang JC, Govindan R, Bauml JM, Garrido P, Krebs MG, Reckamp KL, Xie J, Curtin JC, Haddish-Berhane N, Roshak A, Millington D, Lorenzini P, Thayu M, Knoblauch RE, Cho BC . 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 . October 2021 . 34339292 . 8791812 . 10.1200/JCO.21.00662 .
  14. Web site: Drug Trials Snapshot: Rybrevant . U.S. Food and Drug Administration (FDA) . 9 May 2023 . 9 May 2023 . 10 May 2023 . https://web.archive.org/web/20230510033900/https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-rybrevant . live .
  15. Web site: Rybrevant: Pending EC decision . European Medicines Agency . 15 October 2021 . 15 October 2021 . 15 October 2021 . https://web.archive.org/web/20211015105732/https://www.ema.europa.eu/en/medicines/human/summaries-opinion/rybrevant . live . Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  16. Web site: Rybrevant EPAR . European Medicines Agency (EMA) . 12 October 2021 . 23 April 2022 . 23 April 2022 . https://web.archive.org/web/20220423231832/https://www.ema.europa.eu/en/medicines/human/EPAR/rybrevant . live . Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  17. Web site: Rybrevant Product information . Union Register of medicinal products . 3 March 2023 . 4 March 2023 . https://web.archive.org/web/20230304103520/https://ec.europa.eu/health/documents/community-register/html/h1594.htm . live .
  18. 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 . Janssen Cilag International NV . GlobeNewswire . 28 June 2024 . 3 July 2024 . 3 July 2024 . https://web.archive.org/web/20240703043957/https://www.globenewswire.com/news-release/2024/06/28/2905915/0/en/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-cel.html . live .
  19. ((World Health Organization)) . 2020 . International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83 . WHO Drug Information . 34 . 1 . 10665/339768 . free . 23 May 2021 . 19 April 2021 . https://web.archive.org/web/20210419172633/https://cdn.who.int/media/docs/default-source/international-nonproprietary-names-%28inn%29/rl83.pdf . live .
  20. Kaplon H, Reichert JM . Antibodies to watch in 2021 . mAbs . 13 . 1 . 1860476 . 2021 . 33459118 . 7833761 . 10.1080/19420862.2020.1860476 . doi . free .
  21. Updated Amivantamab and Lazertinib Combination Data Demonstrate Durable Responses and Clinical Activity for Osimertinib-Relapsed Patients with EGFR-Mutated Non-Small Cell Lung Cancer . Janssen Pharmaceutical Companies . Business Wire . 20 May 2021 . 23 May 2021 . 22 May 2021 . https://web.archive.org/web/20210522070803/https://www.businesswire.com/news/home/20210520006102/en/Updated-Amivantamab-and-Lazertinib-Combination-Data-Demonstrate-Durable-Responses-and-Clinical-Activity-for-Osimertinib-Relapsed-Patients-with-EGFR-Mutated-Non-Small-Cell-Lung-Cancer . live .

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