SUMMARY

• RYBREVANT (amivantamab-vmjw) is a low fucose, fully-human immunoglobulin G1 (IgG1)-based bispecific antibody with immune cell-directing activity that targets epidermal growth factor receptor (EGFR) mutations and mesenchymal-epithelial transition (MET) mutations and amplifications in non-small cell lung cancer (NSCLC).¹
• There are no human or animal data to assess the risk of RYBREVANT in pregnancy. Administration of other EGFR and MET inhibitor molecules to pregnant animals has resulted in an increased incidence of impairment of embryo-fetal development, embryolethality, and abortion. Therefore, based on its mechanism of action and findings in animal models, RYBREVANT could cause fetal harm when administered to a pregnant female.²
• RYBREVANT should not be used during pregnancy unless the benefit of treatment to the patient is considered to outweigh potential risks to the fetus. If the patient becomes pregnant while taking this drug, the patient should be informed of the potential risk to the fetus.²
• It is not known whether RYBREVANT is excreted in human or animal milk or affects milk production. Because of the potential for serious adverse reactions from RYBREVANT in breastfed infants, advise patients not to breastfeed during treatment with RYBREVANT and for 3 months following the last dose of RYBREVANT.²
• Due to the risk that RYBREVANT can cause fetal harm when administered to pregnant females, advise female patients of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of RYBREVANT. Male patients must use effective contraception (eg, condoms) and not donate or store semen during treatment and for 3 months after the last dose of RYBREVANT.²
• No data are available to determine potential effects of RYBREVANT on fertility in males or females.²

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) was conducted on 07 March 2024.