The U.S. Food and Drug Administration (FDA) approved a supplemental application for Darzalex Faspro (daratumumab and hyaluronidase-fihj (human recombinant)) on November 19, 2025. This approval, classified for efficacy, was granted to sponsor Janssen Biotech.
Background
Darzalex Faspro is a co-formulation containing daratumumab and hyaluronidase-fihj (human recombinant). This supplemental approval pertains to the efficacy of this specific formulation.
What this means
The FDA's approval of this supplemental application for Darzalex Faspro indicates a regulatory affirmation of its efficacy. This allows Janssen Biotech to update the drug's label, potentially clarifying its benefits based on the data submitted for this efficacy class approval.
Source
The information regarding this supplemental approval was obtained from the U.S. Food and Drug Administration (FDA) on November 19, 2025, as documented on accessdata.fda.gov. The specific application is BLA 761145 S-32.