ODAC votes for Darzalex in smoldering multiple myeloma

This week’s two-day Oncologic Drugs Advisory Committee meeting, which considered three label expansions and one new product, supported the risk-benefit profile of only one: Darzalex Faspro daratumumab/hyaluronidase to treat high-risk smoldering multiple myeloma. 

Darzalex sponsor Johnson & Johnson (NYSE:JNJ) said about 15% of the 35,000 annual multiple myeloma diagnoses in the U.S. are classified as smoldering, but no treatment is currently approved. About 50% of patients with high-risk smoldering myeloma will develop active disease within two to three years, the pharma said...