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
• Verify the pregnancy status of patients of reproductive potential prior to initiating RYBREVANT.²
• Based on the mechanism of action and findings in animal models, RYBREVANT can cause fetal harm when administered to a pregnant patient. Advise pregnant patients and patients of reproductive potential of the potential risk to a fetus.²
  • Advise patients of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of RYBREVANT.
• Because of the potential for serious adverse reactions from RYBREVANT in breastfed children, advise patients not to breastfeed during treatment with RYBREVANT and for 3 months after the last dose.²
• Please refer to RYBREVANT product labeling for additional information.²

USE IN PATIENTS OF REPRODUCTIVE POTENTIAL AND LACTATING PATIENTS

Use in Patients of Reproductive Potential

RYBREVANT can cause fetal harm when administered to a pregnant patient. Advise patients of reproductive potential of the potential risk to a fetus.²

Pregnancy Testing

• Verify the pregnancy status of patients of reproductive potential prior to initiating RYBREVANT.²

Contraception

Females

• Advise patients of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of RYBREVANT.²

Use in Pregnant Patients

• Based on the mechanism of action and findings in animal models, RYBREVANT can cause fetal harm when administered to a pregnant patient. There are no available data on the use of RYBREVANT in pregnant patients or animal data to assess the risk of RYBREVANT in pregnancy.²
• Administration of other epidermal growth factor receptor (EGFR) inhibitor molecules to pregnant animals has resulted in an increased incidence of impairment of embryo-fetal development, embryo lethality, and abortion. Advise pregnant patients of the potential risk to a fetus.²

Use in Lactating Patients

• There are no data on the presence of amivantamab-vmjw in human milk, the effects on the breastfed child, or on milk production.²
• Because of the potential for serious adverse reactions from RYBREVANT in breastfed children, advise patients not to breastfeed during treatment with RYBREVANT and for 3 months after the last dose.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 11 February 2026.