Amivantamab/hyaluronidase

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Amivantamab/hyaluronidase
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
  • None
Legal status
Legal status

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]

Contents

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]

Society and culture

Amivantamab/hyaluronidase was approved for medical use in the United States in December 2025. [3] [4]

Names

Amivantamab/hyaluronidase is sold under the brand name Rybrevant Faspro. [2]

References

  1. 1 2 3 4 "RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj)" (PDF). Janssen Biotech, Inc. U.S. Food and Drug Administration. December 2025.
  2. 1 2 3 4 5 6 7 8 9 10 11 12 "FDA approves amivantamab and hyaluronidase-lpuj for subcutaneous injection". U.S. Food and Drug Administration (FDA). 17 December 2025. Retrieved 29 December 2025.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  3. ↑ "U.S. FDA Approval of Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) Enables the Simplest, Shortest Administration Time for a First-Line Combination Regimen when combined with Lazcluze (lazertinib)" (Press release). Johnson & Johnson. 17 December 2025. Retrieved 29 December 2025.
  4. ↑ "U.S. FDA Approves Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) Co-Formulated with Enhanze for the Treatment of Advanced EGFR-mutated Non-Small Cell Lung Cancer" (Press release). Halozyme Therapeutics. 18 December 2025. Retrieved 29 December 2025– via PR Newswire.


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