U.S. 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
J&J(JNJ) Prnewswire·2025-05-21 06:21ODAC recommendation based on the positive progression-free survival and clinical benefit in the Phase 3 AQUILA studyIf approved, DARZALEX FASPRO® would be the first treatment to potentially delay or prevent progression to multiple myelomaRARITAN, N.J., May 20, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) announced today the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted (6-2) in favor of the benefit-risk profile of single-agent DARZALEX FASPRO® (daratumumab and ...