Chemistry:Amivantamab

From HandWiki

Amivantamab, sold under the brand name Rybrevant, is a bispecific monoclonal antibody used to treat non-small cell lung cancer.[1][2][3][4] Amivantamab is a bispecific epidermal growth factor (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.[2]

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.[2][3]

Amivantamab was approved for medical use in the United States in May 2021,[2][3][5][6] and in the European Union in December 2021.[4] The US Food and Drug Administration considers it to be a first-in-class medication.[7]

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.[3]

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.[8] 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.[8] The FDA previously granted accelerated approval for this indication.[8] The expanded indication for amivantamab was approved in the European Union in July 2024.[9]

In August 2024, the FDA approved lazertinib, in combination with amivantamab, for the treatment of non-small lung cancer.[10]

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.[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.[3] 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.[3] 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).[3] The application reviews are ongoing at the other regulatory agencies.[3]

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.[8] 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.[8] The FDA previously granted accelerated approval for this indication.[8] 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.[8] Participants were randomized 1:1 to receive amivantamab with carboplatin and pemetrexed or carboplatin and pemetrexed.[8]

Society and culture

Amivantamab was approved for medical use in the United States in May 2021.[2][3][5][6]

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.[4][15] The conditional marketing authorization was converted to a standard marketing authorization in July 2024.[9][16]

Names

Amivantamab is the 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. ↑ Cite error: Invalid <ref> tag; no text was provided for refs named Rybrevant FDA label
  2. ↑ 2.0 2.1 2.2 2.3 2.4 Cite error: Invalid <ref> tag; no text was provided for refs named FDA PR 20210521
  3. ↑ 3.0 3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 "FDA grants accelerated approval to amivantamab-vmjw for metastatic non-small cell lung cancer". 21 May 2021. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-amivantamab-vmjw-metastatic-non-small-cell-lung-cancer.  Public Domain This article incorporates text from this source, which is in the public domain.
  4. ↑ 4.0 4.1 4.2 "Rybrevant EPAR". 12 October 2021. https://www.ema.europa.eu/en/medicines/human/EPAR/rybrevant.  Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  5. ↑ 5.0 5.1 "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.
  6. ↑ 6.0 6.1 "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.
  7. ↑ (PDF) Advancing Health Through Innovation: New Drug Therapy Approvals 2021 (Report). 13 May 2022. https://www.fda.gov/media/155227/download. Retrieved 22 January 2023.  Public Domain This article incorporates text from this source, which is in the public domain.
  8. ↑ 8.0 8.1 8.2 8.3 8.4 8.5 8.6 8.7 "FDA approves amivantamab-vmjw for EGFR exon 20 insertion-mutated non-small cell lung cancer indications". 1 March 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-vmjw-egfr-exon-20-insertion-mutated-non-small-cell-lung-cancer-indications.  Public Domain This article incorporates text from this source, which is in the public domain.
  9. ↑ 9.0 9.1 "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.
  10. ↑ "FDA approves lazertinib with amivantamab-vmjw for non-small lung cancer". 19 August 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lazertinib-amivantamab-vmjw-non-small-lung-cancer. 
  11. ↑ "FDA approves amivantamab-vmjw with carboplatin and pemetrexed for non-small cell lung cancer with EGFR exon 19 deletions or L858R mutations". 19 September 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-vmjw-carboplatin-and-pemetrexed-non-small-cell-lung-cancer-egfr-exon-19.  Public Domain This article incorporates text from this source, which is in the public domain.
  12. ↑ 12.0 12.1 12.2 "Drug Trials Snapshot: Rybrevant". U.S. Food and Drug Administration (FDA). 9 May 2023. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-rybrevant.  Public Domain This article incorporates text from this source, which is in the public domain.
  13. ↑ "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. doi:10.1200/JCO.21.00662. PMID 34339292. 
  14. ↑ 14.0 14.1 "Rybrevant: Pending EC decision". 15 October 2021. https://www.ema.europa.eu/en/medicines/human/summaries-opinion/rybrevant.  Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  15. ↑ "Rybrevant Product information". https://ec.europa.eu/health/documents/community-register/html/h1594.htm. 
  16. ↑ "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.
  17. ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83". WHO Drug Information 34 (1). 2020. 
  18. ↑ "Antibodies to watch in 2021". mAbs 13 (1). 2021. doi:10.1080/19420862.2020.1860476. 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.

 This article incorporates public domain material from the United States Department of Health and Human Services website http://www.fda.gov.

Further reading

  • 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
  • Clinical trial number NCT04487080 for "A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (MARIPOSA)" at ClinicalTrials.gov
  • Clinical trial number NCT04988295 for "A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure (MARIPOSA-2)" at ClinicalTrials.gov
  • Clinical trial number NCT04538664 for "A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions (PAPILLON)" at ClinicalTrials.gov



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