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 ATC ClassSourced to the subject's own accountL: Antineoplastic and Immunomodulating Agents 2 Route of Administration First Approved / Isolated Year 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.
View the Source2. Anatomical Therapeutic Chemical Classification System (Wikipedia)
WikipediaFirst-level anatomical group codes, Code LQuote, First-level anatomical group codes, Code L
Antineoplastic and immunomodulating agents
View the Source 3. Drugs.com: Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) FDA Approval History
FDA Approval HistoryQuote, FDA Approval History
Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) was FDA approved on December 17, 2025
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