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) in those with high-risk SMM
- Johnson & Johnson also submitted an sBLA to the FDA on November 8, 2024. The data from the study was presented at ASH’25 and also published in the New England Journal of Medicine
Ref: Johnson & Johnson | Image: Johnson & Johnson| Press Release
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