The U.S. Food and Drug Administration (FDA) approved Rybrevant Faspro (amivantamab and hyaluronidase-lpuj (human recombinant)) on February 13, 2026. This approval introduces a new formulation of amivantamab, which is also known by its brand name Rybrevant.
Background
Amivantamab, the active pharmaceutical ingredient in Rybrevant Faspro, is an existing therapeutic agent. The approval of Rybrevant Faspro falls under a Type 5 classification by the FDA, indicating it is a new formulation or new manufacturer. The sponsor responsible for this approval is JANSSEN BIOTECH. The new formulation combines amivantamab with hyaluronidase-lpuj (human recombinant).
What this means
The introduction of Rybrevant Faspro, a new formulation incorporating hyaluronidase, often aims to enhance the administration experience for patients and healthcare providers. Such formulations typically facilitate more convenient delivery methods, potentially reducing treatment burden or improving accessibility. This approval expands the therapeutic options available for patients currently treated with amivantamab, offering a potentially optimized version of the drug.
Source
The information regarding this FDA approval was sourced from the U.S. Food and Drug Administration (FDA) on February 13, 2026. The details are publicly accessible on the accessdata.fda.gov website under BLA 761484.