The U.S. Food and Drug Administration (FDA) granted a supplemental efficacy approval for Darzalex Faspro (daratumumab and hyaluronidase-fihj) on January 27, 2026. This approval, designated as BLA 761145 S-28, expands the drug's approved uses based on new efficacy data.
Background
Darzalex Faspro is sponsored by Janssen Biotech. This supplemental application specifically addresses the efficacy of the drug, indicating an expansion of its demonstrated effectiveness.
What this means
A supplemental efficacy approval signifies that the FDA has recognized additional benefits or expanded indications for Darzalex Faspro. This typically allows the drug to be used in new patient populations or for new disease contexts, providing more treatment options for clinicians and patients.
Source
The information regarding this approval was obtained from the U.S. Food and Drug Administration (FDA) website. The supplemental application for Darzalex Faspro (BLA 761145 S-28) was approved on January 27, 2026, and is documented on accessdata.fda.gov.