Source: Healio News
The FDA approved daratumumab and hyaluronidase-fihj for use in combination with pomalidomide and dexamethasone for treatment of patients with relapsed multiple myeloma, including those refractory to lenalidomide.
Daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen) is the only subcutaneous anti-CD38 monoclonal antibody approved in combination with pomalidomide (Pomalyst, Bristol Myers Squibb) and dexamethasone.
The FDA based the approval on results of the randomized phase 3 APOLLO study, which included 304 patients with relapsed or refractory multiple myeloma who received at least one