Amivantamab

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Amivantamab
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
Antineoplastic
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

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

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]

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).[12]

Amivantamab may cause serious side effects including infusion-related reactions, lung inflammation, skin problems, eye problems, and harm to an unborn baby.[12]

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

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

Legal status

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.[14] The applicant for this medicinal product was Janssen-Cilag International N.V.[14] Amivantamab was approved for medical use in the European Union in December 2021.[7][15]

In November 2023, Janssen applied to the EMA for the approval of amivantamab in combination with chemotherapy (

non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations, after failure of prior therapy including a third-generation EGFR tyrosine kinase inhibitor (TKI).[16]

Names

Amivantamab is the recommended international nonproprietary name (INN).[17]

Research

Amivantamab is being investigated in combination with lazertinib versus osimertinib; and in combination with carboplatin-pemetrexed chemotherapy compared to carboplatin-pemetrexed.[18][19]

References

  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 © 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 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.
  13. PMID 34339292
    .
  14. ^ 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 © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  15. ^ "Rybrevant Product information". Union Register of medicinal products. Archived from the original on 4 March 2023. Retrieved 3 March 2023.
  16. ^ "Janssen files for EMA approval of Rybrevant". www.thepharmaletter.com. Retrieved 30 November 2023.
  17. hdl:10665/339768. Archived
    (PDF) from the original on 19 April 2021. Retrieved 23 May 2021.
  18. PMID 33459118
    .
  19. ^ "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

External links
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