RYBREVANT amivantamab

Drug Class

Bispecific EGFR-MET antibody

Mechanism

Binds to extracellular domains of EGFR and MET, blocking ligand binding, promoting receptor downregulation, and inducing antibody-dependent cellular cytotoxicity (ADCC).

Approved Indication

EGFR exon 20 insertion mutation-positive advanced NSCLC, and EGFR exon 19 deletion or L858R substitution-positive advanced NSCLC (in combination with lazertinib), per its FDA approval.

What This Means For Patients

Rybrevant is a targeted bispecific antibody for patients with advanced non-small cell lung cancer with specific EGFR mutations, including exon 20 insertions or exon 19/21 mutations. It targets both the EGFR and MET receptors to inhibit tumor growth and is available under special import rules at Hainan Boao Lecheng.

Regulatory Approvals

• FDA — approved (2021) — label
• EMA — approved (2021) — source

Pivotal Clinical Evidence

• CHRYSALIS — Park et al., J Clin Oncol 2021 (NCT02609776) — DOI

Sources

• https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-amivantamab-vmjw-metastatic-nsclc-egfr-exon-20-insertion-mutations
• https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761210s000lbl.pdf