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NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®)

• NCCN Guidelines^® for Non-Small Cell Lung Cancer (NSCLC) recommends either amivantamab and hyaluronidase-lpuj (RYBREVANT FASPRO) or amivantamab-vmjw (RYBREVANT) for epidermal growth factor receptor (EGFR) Exon 19 deletion or Exon 21 L858R mutation positive advanced or metastatic NSCLC as follows¹:
  • A first-line therapy option in combination with lazertinib (LAZCLUZE) for EGFR mutation discovered prior to first-line systemic therapy (NCCN Category 1, Preferred) or during first-line systemic therapy (NCCN Category 2A), regardless of tumor histology.
    • A subsequent therapy option to continue therapy in combination with lazertinib (LAZCLUZE) following disease progression on either amivantamab and hyaluronidase-lpuj + lazertinib or amivantamab-vmjw + lazertinib for asymptomatic disease, symptomatic brain lesions, or symptomatic, systemic, limited progression, regardless of tumor histology (NCCN Category 2A).
  • A subsequent therapy option in combination with carboplatin and pemetrexed following disease progression on osimertinib or lazertinib (LAZCLUZE) for symptomatic, systemic disease with multiple lesions (if not previously given), for nonsquamous histology (NCCN Category 1, Preferred).
  • A subsequent therapy option in combination with lazertinib (LAZCLUZE) following disease progression on osimertinib for symptomatic, systemic disease with multiple lesions (if not previously given), regardless of tumor histology (NCCN Category 2A, Useful in certain circumstances).
  • A subsequent therapy option in combination with lazertinib (LAZCLUZE) following disease progression on osimertinib/(carboplatin or cisplatin)/pemetrexed (if not previously given), for nonsquamous histology (NCCN Category 2A, Other recommended).
• NCCN Guidelines for NSCLC recommends either amivantamab and hyaluronidase-lpuj (RYBREVANT FASPRO) or amivantamab-vmjw (RYBREVANT) for EGFR Exon 20 insertion mutation positive advanced or metastatic NSCLC as follows¹:
  • A first-line therapy option in combination with carboplatin and pemetrexed, for nonsquamous histology (NCCN Category 1, Preferred).
  • A subsequent therapy option as a single agent (if not received previously), regardless of tumor histology (NCCN Category 2A).
• NCCN Guidelines for NSCLC states that amivantamab and hyaluronidase-lpuj (RYBREVANT FASPRO) subcutaneous injection may be substituted for intravenous amivantamab-vmjw (RYBREVANT). Amivantamab and hyaluronidase-lpuj (RYBREVANT FASPRO) has different dosing and administration instructions compared to amivantamab-vmjw (RYBREVANT).¹ 
• NCCN Guidelines for NSCLC recommends prophylaxis with the following when administering either amivantamab and hyaluronidase-lpuj (RYBREVANT FASPRO) or amivantamab-vmjw (RYBREVANT)¹:
  • For amivantamab and hyaluronidase-lpuj (RYBREVANT FASPRO) + lazertinib (LAZCLUZE) or amivantamab-vmjw (RYBREVANT) + lazertinib (LAZCLUZE), prophylactic anticoagulation is recommended at the time of initiation to prevent venous thromboembolic events. 
  • Prophylaxis with oral doxycycline or minocycline, clindamycin lotion applied to the scalp, chlorhexidine applied to nails, and a ceramide-based non-comedogenic moisturizer is recommended to reduce dermatologic adverse events.
  • Prophylaxis with oral dexamethasone 8 mg for 2 days prior to first dose is recommended to reduce infusion-related reactions (IRRs) with amivantamab-vmjw (RYBREVANT).
• NCCN Categories of Evidence are defined as follows¹:
  • Category 1 is based upon high-level evidence (≥1 randomized phase 3 trials or high-quality, robust meta analyses), and there is uniform NCCN consensus (≥85% support of the Panel) that the intervention is appropriate.
  • Category 2A is based upon lower-level evidence, and there is uniform NCCN consensus (≥85% support of the Panel) that the intervention is appropriate.
• NCCN Categories of Preference are defined as follows¹:
  • Preferred intervention is defined as interventions that are based on superior efficacy, safety, and evidence; and, when appropriate, affordability.
  • Other recommended intervention is defined as other interventions that may be somewhat less efficacious, more toxic, or based on less mature data; or significantly less affordable for similar outcomes.
  • Useful in certain circumstances intervention is defined as other interventions that may be used for selected patient populations (defined with recommendation).
• Please refer to the NCCN Guidelines for NSCLC at www.nccn.org for current and complete recommendations for the use of amivantamab and hyaluronidase-lpuj (RYBREVANT FASPRO) or amivantamab-vmjw (RYBREVANT) in NSCLC.¹ 
• Please refer to the full Prescribing Information for RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj), RYBREVANT (amivantamab-vmjw), and LAZCLUZE (lazertinib) for information on INDICATIONS & USAGE.^2-4    

PRODUCT LABELING

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