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DARZALEX (Daratumumab) Receives Positive CHMP Opinion for High-Risk Smouldering Multiple Myeloma

Shots: Janssen-Cilag (Johnson & Johnson) announced that the CHMP of the EMA has recommended approving DARZALEX (daratumumab) SC as the first therapy for adults with high‑risk smouldering multiple myeloma (SMM) The CHMP’s recommendation is based on the P-III (AQUILA) study data evaluating efficacy and safety of fixed-duration monotx. daratumumab SC compared with active monitoring (N=390)…

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