Amivantamab

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Amivantamab
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetEpidermal growth factor receptor (EGFR) and Mesenchymal–epithelial transition (MET)
Names
Trade namesRybrevant
Other namesJNJ-61186372, amivantamab-vmjw
Clinical data
Drug classAntineoplastic
Main usesNon-small cell lung cancer[1][2]
Side effectsRash, infusion reaction, infection around the nail, muscle and joint pain, shortness of breath, nausea, tiredness, swelling, sores in the mouth, cough, constipation[1]
Routes of
use
Intravenous infusion
Typical dose1050 to 1400 mg[1]
External links
AHFS/Drugs.comMonograph
US NLMAmivantamab
Legal
License data
Legal status
Chemical and physical data
FormulaC6472H10014N1730O2023S46
Molar mass145902.15 g·mol−1

Amivantamab, sold under the brand name Rybrevant, is a medications used to treat non-small cell lung cancer.[1][2] Specifically it is used for advanced cases with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, who have failed other treatments.[1] It is given by injection into a vein.[1]

Common side effects include rash, infusion reaction, infection around the nail, muscle and joint pain, shortness of breath, nausea, tiredness, swelling, sores in the mouth, cough, and constipation.[1] Other side effects may include pneumonitis, eye problems, low potassium, high blood sugar, low sodium, and liver inflammation.[1] Use in pregnancy may harm the baby.[1] It is a bispecific monoclonal antibody that attaches to epidermal growth factor (EGF) receptor and mesenchymal–epithelial transition (MET) receptor.[1]

Amivantamab was approved for medical use in the United States and Europe in 2021.[1][2] In the United Kingdom it costs the NHS about £1,100 for a 350 mg vial as of 2022.[7] This amount in the United States costs about 3,500 USD.[8]

Medical uses

Amivantamab is 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.[6]

Dosage

It is usually used at a dose of 1050 mg in those under 80 kg and 1400 mg in those over 80 kg.[1]

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.[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).[9]

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]

Society and culture

Legal status

Amivantamab was approved for medical use in the United States in May 2021.[5][6] On 14 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.[10] The applicant for this medicinal product is Janssen-Cilag International N.V.[10] Amivantamab was approved for medical use in the European Union in December 2021.[2]

Names

Amivantamab is the recommended international nonproprietary name (INN).[11]

Research

Amivantamab is being investigated in combination with lazertinib versus osimertinib; and in combination with carboplatin-pemetrexed chemotherapy compared to carboplatin-pemetrexed.[12][13]

References

  1. 1.00 1.01 1.02 1.03 1.04 1.05 1.06 1.07 1.08 1.09 1.10 1.11 1.12 "Rybrevant- amivantamab injection". DailyMed. Janssen Pharmaceutical Companies. Archived from the original on 26 May 2021. Retrieved 25 May 2021.
  2. 2.0 2.1 2.2 2.3 2.4 "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.
  3. "Rybrevant Product information". Health Canada. 25 April 2012. Archived from the original on 29 June 2022. Retrieved 29 June 2022.
  4. "Summary Basis of Decision - Rybrevant". Health Canada. 23 October 2014. Archived from the original on 6 August 2022. Retrieved 6 August 2022.
  5. 5.0 5.1 "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. 6.0 6.1 6.2 6.3 6.4 6.5 6.6 "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. "Amivantamab". SPS - Specialist Pharmacy Service. 9 December 2020. Archived from the original on 2 March 2022. Retrieved 29 October 2022.
  8. "Rybrevant Prices, Coupons, Copay & Patient Assistance". Drugs.com. Retrieved 29 October 2022.
  9. 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 (20 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.{{cite journal}}: CS1 maint: PMC embargo expired (link)
  10. 10.0 10.1 "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.
  11. World Health Organization (2020). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83" (PDF). WHO Drug Information. 34 (1). Archived (PDF) from the original on 19 April 2021. Retrieved 23 May 2021.
  12. Kaplon H, Reichert JM (2021). "Antibodies to watch in 2021". mAbs. 13 (1): 1860476. doi:10.1080/19420862.2020.1860476. PMC 7833761. PMID 33459118.
  13. "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

External links

External sites:
Identifiers:
  • 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