1 December 2021 - On 30 November 2021, the FDA approved daratumumab with hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech) in combination with carfilzomib (Kyprolis, Amgen) and 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, a multi-cohort, open-label trial.

Read FDA press release