FDA Oncologic Drugs Advisory Committee votes in favor of the benefit-risk profile of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for high-risk smoldering multiple myeloma

The U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) has voted 6-2 in favor of the benefit-risk profile of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) as a monotherapy for adults with high-risk smoldering multiple myeloma...