FDA approves subcutaneous daratumumab + Pd for the treatment of R/R MM

On July 9, 2021, the combination of subcutaneous daratumumab with pomalidomide and dexamethasone (Pd) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed/refractory (R/R) multiple myeloma (MM).

The combination is indicated for the treatment of patients who have received ≥1 prior line of therapy, including lenalidomide and a proteasome inhibitor. Encouraging outcomes from the phase III APOLLO study (NCT03180736) aided the decision.

A request for approval of the combination was submitted to the FDA and European Medicines Agency (EMA) in November 2020, and the European Commission (EC) granted an extended marketing authorization to the combination in June 2021.