Guidelines for Use
GUIDELINES FOR USE
Our guideline name AMIVANTAMAB-VMJW (Rybrevant) requires the following rule(s) be met for approval:
- You have locally advanced or metastatic non-small cell lung cancer (NSCLC: a type of lung cancer that has spread to nearby tissue, lymph nodes, or other parts of the body)
- You are 18 years of age or older
- If you have epidermal growth factor receptor (EGFR: type of protein) exon 19 deletions or exon 21 L858R substitution mutations (abnormal changes in a type of gene), approval also requires ONE of the following:
- Your mutation is detected by a Food and Drug Administration (FDA)-approved test AND Rybrevant will be used in combination with lazertinib (Lazcluze)
- Rybrevant will be used in combination with carboplatin and pemetrexed AND your disease has progressed while on or after epidermal growth factor receptor (EGFR) tyrosine kinase-inhibitor therapy (such as Tagrisso [osimertinib], Tarceva [erlotinib], Iressa [gefitinib], Gilotrif [afatinib])
- If you have epidermal growth factor receptor (EGFR: type of protein) exon 20 insertion mutations (abnormal changes in a type of gene), as detected by a Food and Drug Administration (FDA)-approved test, approval also requires you meet ONE of the following:
- Rybrevant will be used in combination with carboplatin and pemetrexed
- Rybrevant will be used as a single agent AND your disease has progressed on or after platinum-based chemotherapy (such as cisplatin, carboplatin)
- Daratumumab-hyaluronidase-fihj and dexamethasone
- Isatuximab and dexamethasone