Amivantamab/hyaluronidase
Medication
From Wikipedia, the free encyclopedia
Amivantamab/hyaluronidase, sold under the brand name Rybrevant Faspro, is a fixed-dose combination medication used for the treatment of non-small cell lung cancer.[1] It contains amivantamab, a bispecific epidermal growth factor receptor (EGFR)-directed and hepatocyte growth factor receptor (MET)-directed antibody; and hyaluronidase, an endoglycosidase.[1] It is given by subcutaneous infusion.[1]
| Combination of | |
|---|---|
| Amivantamab | Bispecific epidermal growth factor receptor (EGFR)-directed and hepatocyte growth factor receptor (MET)-directed antibody |
| Hyaluronidase | Endoglycosidase |
| Clinical data | |
| Trade names | Rybrevant Faspro |
| AHFS/Drugs.com | rybrevant-faspro |
| License data | |
| Routes of administration | Subcutaneous |
| ATC code |
|
| Legal status | |
| Legal status | |
Amivantamab/hyaluronidase was approved for medical use in the United States in December 2025.[2]
Medical uses
Amivantamab/hyaluronidase is indicated in combination with lazertinib for the first-line treatment of adults with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test;[2] in combination with carboplatin and pemetrexed for the treatment of adults with locally advanced or metastatic non-small cell lung cancer 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;[2] in combination with carboplatin and pemetrexed for the first-line treatment of adults with locally advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations, as detected by an FDA-approved test;[2] as a single agent for the treatment of adults with locally advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations, as detected by an FDA approved test, whose disease has progressed on or after platinum-based chemotherapy.[2]
Adverse effects
The US prescribing information includes warnings and precautions for hypersensitivity and administration-related reactions, interstitial lung disease/pneumonitis, venous thromboembolic events with concomitant use with lazertinib, dermatologic adverse reactions, ocular toxicity, and embryo-fetal toxicity.[2]
History
The subcutaneous injection of amivantamab and hyaluronidase was evaluated in PALOMA-3, a randomized, open-label, multi-center, multi-regional trial in adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR-exon 19 deletions or exon 21 L858R substitution mutations.[2] A total of 418 participants were randomized (1:1) to receive either subcutaneous amivantamab and hyaluronidase plus lazertinib or intravenous amivantamab plus lazertinib.[2]
The safety profile of the subcutaneous amivantamab arm was generally similar to the safety profile of the intravenous amivantamab IV arm in PALOMA-3.[2] One exception is that the incidence of systemic administration reactions (ARRs) for subcutaneous amivantamab SC was lower than the incidence of infusion related reactions (IRRs) for intravenous amivantamab.[2] The incidence of systemic ARRs of any grade was 13% for subcutaneous amivantamab compared to 66% IRRs for intravenous amivantamab.[2]
