The U.S. Food and Drug Administration (FDA) granted approval for Rybrevant Faspro (amivantamab and hyaluronidase-lpuj (human recombinant)), a new formulation of amivantamab, on 2025-12-17. This approval, designated as a Type 5 classification, signifies a new formulation or new manufacturer for the drug.
Background
Amivantamab, also known by its brand name Rybrevant, is an existing therapeutic agent. The newly approved Rybrevant Faspro represents a new formulation which includes amivantamab and hyaluronidase-lpuj (human recombinant). The sponsor for this approval is Janssen Biotech. The FDA classified this approval as a Type 5, which indicates either a new formulation of an existing drug or a new manufacturer for an existing drug product.
What this means
The approval of a new formulation like Rybrevant Faspro often aims to improve aspects of drug administration or patient experience. While specific details regarding the changes are not provided in the approval data, new formulations can offer benefits such as different routes of administration, reduced treatment times, or enhanced convenience for patients and healthcare providers. The inclusion of hyaluronidase (human recombinant) in the formulation typically facilitates subcutaneous delivery, which can offer a less invasive and potentially more convenient option compared to traditional intravenous infusions. This development could broaden the accessibility and practical application of amivantamab for patients.
Source
The information regarding the approval of Rybrevant Faspro was obtained from the U.S. Food and Drug Administration (FDA). This initial approval (BLA 761433) was documented on 2025-12-17 on the accessdata.fda.gov website.