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These highlights do not include all the information needed to use RYBREVANT FASPRO safely and effectively. See full prescribing information for RYBREVANT FASPRO. RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) injection, for subcutaneous use Initial U.S. Approval: 2025
Medication labelWhy this: Advisory · dailymed-prescription
RYBREVANT FASPRO, in combination with lazertinib, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test [see Dosage and Administration (2.2)]. RYBREVANT FASPRO, in combination with carboplatin and pemetrexed, is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor [see Dosage and Administration (2.2)]. RYBREVANT FASPRO, in combination with carboplatin and pemetrexed, is indicated for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test [see Dosage and Administration (2.2)]. RYBREVANT FASPRO is indicated as a single agent for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test [see Dosage and Administration (2.2)], whose disease has progressed on or after platinum-based chemotherapy.
- generic_name
- amivantamab and hyaluronidase-lpuj (human recombinant)
- product_names
- AMIVANTAMAB and HYALURONIDASE-lpuj (HUMAN RECOMBINANT)
- ndc
- 57894-510, 57894-514, 57894-515, 57894-522, 57894-510-01, 57894-514-01, 57894-515-01, 57894-522-01
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en