Posted by Michael Wonder on 27 Jan 2026
FDA approves daratumumab and hyaluronidase-fihj with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma
27 January 2026 - Today, the FDA approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech) in combination with bortezomib, lenalidomide, and dexamethasone for adults with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
Efficacy was evaluated in CEPHEUS, an open-label, randomised, active-controlled trial in patients with newly diagnosed multiple myeloma who were ineligible for autologous stem cell transplant or refused autologous stem cell transplant as initial therapy.
