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Drugs and Medicinal Substances

Amivantamab/hyaluronidase

Antineoplastic and Immunomodulating Agents

Amivantamab/hyaluronidase, marketed as Rybrevant Faspro, is a fixed-dose combination medication for non-small cell lung cancer. It pairs amivantamab, a bispecific antibody that targets the EGFR and MET receptors involved in tumor growth, with hyaluronidase, an enzyme that breaks down tissue barriers to allow the antibody to be absorbed after a subcutaneous injection rather than an intravenous infusion. It is indicated for advanced non-small cell lung cancer carrying specific EGFR mutations, including exon 19 deletions, the exon 21 L858R substitution, or exon 20 insertions, either as a first treatment or after an earlier treatment has failed. The subcutaneous formulation causes fewer administration reactions than the original intravenous version of amivantamab. It was approved for medical use in the United States in December 2025.

Facts
Classification
Approval Status
Approved 1
ATC ClassSourced to the subject's own account
L: Antineoplastic and Immunomodulating Agents 2
Route of Administration
Subcutaneous 1
First Approved / Isolated Year
2025 3
Sources
1. Amivantamab/hyaluronidase (Wikipedia)
  • Lead section, approval-status statement
    Amivantamab/hyaluronidase was approved for medical use in the United States in December 2025.
  • Lead section, route-of-administration statement
    It is given by subcutaneous infusion.
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2. Anatomical Therapeutic Chemical Classification System (Wikipedia)
WikipediaFirst-level anatomical group codes, Code L
Quote, First-level anatomical group codes, Code L
Antineoplastic and immunomodulating agents
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3. Drugs.com: Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) FDA Approval History
FDA Approval History
Quote, FDA Approval History
Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) was FDA approved on December 17, 2025
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