Johnson & Johnson’s Darzalex (daratumumab) Receives the CHMP’s Positive Opinion for Multiple Myeloma
Shots:
- The CHMP has recommended Darzalex (SC) + bortezomib, lenalidomide & dexamethasone (D-VRd) to treat newly diagnosed multiple myeloma pts.
- Opinion was based on P-III (CEPHEUS) trial, which assessed efficacy & safety in transplant-ineligible or deferred NDMM pts (n=395) not planned for ASCT as initial therapy, in 13 countries across North America, South America and EU
- The study focused on overall MRD negativity (1EP), with participants aged 18+ and a median age of 70 (range: 31–80) in both D-VRd & VRd arms. Data was presented at the 2024 IMS and ASH Annual Meetings
Ref: Johnson & Johnson | Image: Johnson & Johnson
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