FDA Panel Votes In Favor Of J&J' DARZALEX FASPRO For High-Risk Smoldering Multiple Myeloma Treatment

(RTTNews) - Johnson & Johnson (JNJ) announced that the U.S. Food and Drug Administration Oncologic Drugs Advisory Committee (ODAC) voted (6-2) in favor of the benefit-risk profile of single-agent DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) for the treatment of adult patients with high-risk smoldering multiple myeloma (HR-SMM).

An application for the approval of DARZALEX FASPRO for adult patients with high-risk smoldering multiple myeloma was submitted to the FDA in November 2024.

The committee reviewed data from the AQUILA study, a Phase 3, randomized, open-label trial which evaluated the efficacy and safety of DARZALEX FASPRO versus SOC active monitoring in patients with HR-SMM.

The ODAC is convened upon request of the FDA to review and evaluate safety and efficacy data of human drug products for use in the treatment of oncologic diseases. The committee provides non-binding recommendations based on its evaluation; however, final decisions on approval of the drug are made by the FDA.

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