Safety Information for RYBREVANT - Ocular Toxicity

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
• LAZCLUZE (lazertinib) is a third-generation EGFR tyrosine kinase inhibitor (TKI).²
• RYBREVANT can cause ocular toxicity including keratitis, blepharitis, dry eye symptoms, conjunctival redness, blurred vision, visual impairment, ocular itching, eye pruritus, and uveitis.³
• In the MARIPOSA study (NCT04487080), ocular toxicity occurred in 16% of patients treated with RYBREVANT in combination with LAZCLUZE, including grade 3 or 4 ocular toxicity in 0.7% of patients.³
  • Withhold, reduce the dose, or permanently discontinue RYBREVANT and continue LAZCLUZE based on severity.
  • The most common adverse reactions (ARs; ≥20%) were rash, nail toxicity, infusion-related reaction, edema, musculoskeletal pain, stomatitis, venous thromboembolic events, paresthesia, fatigue, diarrhea, constipation, coronavirus disease 2019 (COVID-19), dry skin, hemorrhage, decreased appetite, pruritus, and nausea.
• In the MARIPOSA-2 study (NCT04988295), ocular toxicity occurred in 17% of patients treated with RYBREVANT in combination with carboplatin and pemetrexed. No grade 3 or 4 ocular toxicity was reported.³
  • Clinically relevant ARs in <10% of patients who received RYBREVANT in combination with carboplatin and pemetrexed included abdominal pain, hemorrhoids, dizziness, visual impairment, trichomegaly, keratitis, interstitial lung disease (ILD), and skin ulcer.
• In a pooled analysis including safety populations from the PAPILLON (NCT04538664) and MARIPOSA-2 (NCT04988295) studies, ocular toxicity occurred in 16% of patients treated with RYBREVANT in combination with carboplatin and pemetrexed. All events were grade 1 or 2.³
• In the CHRYSALIS study (NCT02609776), keratitis occurred in 0.7% and uveitis occurred in 0.3% of patients treated with RYBREVANT. All events were grade 1 or 2.³
  • Clinically relevant ARs in <10% of patients who received RYBREVANT included ocular toxicity, ILD/pneumonitis, and toxic epidermal necrolysis.
• Advise patients of the risk of ocular toxicity.³
• Advise patients to contact their ophthalmologist if they develop eye symptoms and advise discontinuation of contact lenses until symptoms are evaluated.³
• Promptly refer patients with worsening eye symptoms to an ophthalmologist.³
• Withhold, reduce the dose, or permanently discontinue RYBREVANT based on severity.³
• Please refer to RYBREVANT product labeling for complete safety information, including dose modification guidelines for ARs.
• Please refer to product labeling for carboplatin and/or pemetrexed for complete prescribing information.

PRODUCT LABELING

• RYBREVANT (amivantamab-vmjw) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://jnjlabels.com/package-insert/product-monograph/prescribing-information/RYBREVANT-pi.pdf.
• LAZCLUZE (lazertinib) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.jnjlabels.com/package-insert/product-monograph/prescribing-information/LAZCLUZE-pi.pdf.

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and DerwentDrug File (and/or other resources, including internal/external databases) was conducted on 06 April  2026. The information included in this response is limited to relevant data from the registrational studies for RYBREVANT.