In a U.S. Food and Drug Administration (FDA) press release on July 30, 2024, the FDA announced its approval of "daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Research & Development, LLC) in combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation in patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT)."
This approval was based on the results of the PERSEUS trial (NCT03710603), "an open-label, randomized, active-controlled trial in patients with newly diagnosed multiple myeloma eligible for ASCT."
Full prescribing information for Darzalex Faspro will be posted on Drugs@FDA.
Read the full press release at the button below to learn more.