Amivantamab

(Rybrevant®)

Rybrevant®

Drug updated on 5/17/2024

Dosage FormInjection (intravenous; 350 mg/7 mL [50 mg/mL])
Drug ClassEGF receptor-directed and MET receptor-directed antibody
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated in combination with carboplatin and pemetrexed for the first-line treatment of adult patients 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.
  • Indicated as a single agent for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

Summary
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  • Amivantamab (Rybrevant) is indicated in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations. It is also used as a single agent for treating adults whose disease has progressed on or after platinum-based chemotherapy.
  • Two studies were reviewed to gather information about this drug, focusing on its safety and effectiveness compared to other drugs in its class.
  • These documents suggest that amivantamab, along with mobocertinib and poziotinib, are leading treatments for NSCLC following prior platinum-based chemotherapy failure. However, gastrointestinal and dermatological adverse reactions have been noted as primary safety concerns.
  • Compared to conventional treatments such as EGFR-TKIs and immuno-oncology agents which show limited efficacy, targeted therapies like Rybrevant could potentially offer significant therapeutic advancement due to their specific targeting of exon 20 insertion mutations.
  • Although there is limited real-world evidence regarding newly approved agents like amivantamab because of the lack of randomized controlled trials, available interventional evidence suggests potential effectiveness, making it an interesting option among others, including osimertinib, pertuzumab-trastuzumab-docetaxel scheme, etc.
  • The studies emphasize populations of adults diagnosed with locally advanced or metastatic NSCLC carrying the specific EGFR exon 20 insertion mutations. Subgroup considerations revolve primarily around comparing first-line therapy outcomes versus second-line or later therapies, indicating broader applicability within this population group.

Product Monograph / Prescribing Information

Document TitleYearSource
Rybrevant (amivantamab-vmjw) Prescribing Information.2024Janssen Biotech, Inc., Horsham, PA

Systematic Reviews / Meta-Analyses