U.S. License Holder:
Janssen Biotech
Date of License:
December-17-2025
Last Update:
November-08-2026
FDA-Approved Indications
RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) is a combination of amivantamab, a bispecific EGF receptor-directed and MET receptor-directed antibody, and hyaluronidase, an endoglycosidase indicated:
In combination with lazertinib for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon?19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test;
In combination with carboplatin and pemetrexed 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;
In combination with carboplatin and pemetrexed 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;
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, whose disease has progressed on or after platinum-based chemotherapy;
As a single agent for the treatment of adult patients with recurrent or metastatic HNSCC whose disease has progressed on or after platinum-based chemotherapy and an anti-PD-(L)1 antibody.