05:03 AM EDT, 05/21/2025 (MT Newswires) -- Johnson & Johnson ( JNJ ) said Tuesday that the US Food and Drug Administration's Oncologic Drugs Advisory Committee has voted in favor of Darzalex Faspro's benefit-risk profile for the treatment of adult patients with high-risk smoldering multiple myeloma.

The company said the committee's recommendation was based one positive progression-free survival and clinical benefit data from a phase 3 study of Darzalex Faspro in comparison with standard of care for high-risk smoldering multiple myeloma.

Johnson & Johnson ( JNJ ) said the committee is convened by the FDA to review and evaluate human drug products for oncologic diseases but the final approval decision remains with the FDA. The application for Darzalex Faspro's approval in high-risk smoldering multiple myeloma was submitted to the FDA in November 2024, the company added.