The U.S. Food and Drug Administration (FDA) granted supplemental approval for Darzalex Faspro (daratumumab and hyaluronidase-fihj (human recombinant)) on November 6, 2025. This supplemental application, identified as BLA 761145 S-29, was specifically approved for efficacy.
Background
Darzalex Faspro is a product sponsored by Janssen Biotech. This supplemental approval pertains to the demonstration of the drug's efficacy, indicating a re-evaluation or expansion of its proven benefits.
What this means
A supplemental approval for efficacy from the FDA signifies that new data supports an expanded or modified use of an existing drug. For Darzalex Faspro, this approval suggests that the drug's demonstrated effectiveness has been confirmed or extended to potentially include new patient populations, different stages of a disease, or alternative treatment regimens. Clinicians and researchers will need to consult the updated label for the specific details of this efficacy expansion, which could influence future treatment strategies and patient management decisions.
Source
This information is based on an FDA supplemental application approval for BLA 761145 S-29, dated November 6, 2025. The details were sourced from the official FDA website, accessdata.fda.gov.