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
  • The most common adverse reactions (ARs; ≥20%) were rash, nail toxicity, infusion-related reaction, edema, musculoskeletal pain, stomatitis, venous thromboembolic event, paresthesia, fatigue, diarrhea, constipation, coronavirus disease 2019 (COVID-19), dry skin, hemorrhage, decreased appetite, pruritus, nausea, and ocular toxicity.³
• 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, and interstitial lung disease (ILD).³
• 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.³
• Advise patients of the risk of ocular toxicity. Promptly refer patients with worsening eye symptoms to an ophthalmologist and advise discontinuation of contact lenses until symptoms are evaluated. 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://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/RYBREVANT-pi.pdf.
• LAZCLUZE (lazertinib) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.janssenlabels.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 8 May 2025. Data reported in pivotal studies included in the product labeling are included in this response.