- FDA Announcements
RRMM:Daratumumab and Hyaluronidase-fihj (Darzalex Faspro) + Pomalidomide (Pomalyst) & Dexamethasone
FDA approved for RRMM: Daratumumab and Hyaluronidase-fihj (Darzalex Faspro) + Pomalidomide (Pomalyst) and Dexamethasone
Relapsed & Refractory Multiple Myeloma
FDA approves daratumumab and hyaluronidase-fihj with pomalidomide and dexamethasone for multiple myeloma
On July 9, 2021, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor.
Efficacy was evaluated in APOLLO (NCT03180736), an open-label, active-controlled trial with 304 patients randomized (1:1) to Darzalex Faspro with pomalidomide and dexamethasone (Pd) vs Pd alone.
Learn more: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-pomalidomide-and-dexamethasone-multiple-myeloma
07/09/2021: FDA Approval