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.
For More Such Health News, visit rttnews.com.
For comments and feedback contact: editorial@rttnews.com
Business News
April 17, 2026 15:29 ET The ongoing conflict in the Middle East continues to raise concerns for policymakers who worry about the impact of the supply shock and high energy prices on the real economy. Producer price data and various survey results on the housing market were the main news from the U.S. this week. In Europe, industrial production data for the euro area gained attention. GDP figures out of China and the policy move by the Singapore central bank were in focus in Asia.