- FDA Announcements
FDA Approved for RRMM:Daratumumab and Hyaluronidase-fihj(Darzalex Faspro) + Kyprolis & Dexamethasone
FDA Approved for RRMM: Daratumumab and Hyaluronidase-fihj (Darzalex Faspro) + Kyprolis & Dexamethasone
FDA approves Darzalex Faspro, Kyprolis, and Dexamethasone for Multiple Myeloma
On November 30, 2021, the Food and Drug Administration approved daratumumab + hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) and carfilzomib (Kyprolis, Amgen, Inc.) plus dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.
Efficacy was evaluated in a single-arm cohort of PLEIADES (NCT03412565), a multi-cohort, open-label trial. This cohort enrolled 66 patients with relapsed or refractory multiple myeloma who received at least one prior line of therapy. Patients received Darzalex Faspro 1,800 mg/30,000 units (1,800 mg daratumumab and 30,000 units hyaluronidase) administered subcutaneously in combination with Kyprolis (20/70 mg/m2 once weekly regimen) and dexamethasone.
11/30/2021: FDA Approval