Johnson & Johnson Receives the EC’s Approval for Darzalex Regimen to Treat Newly Diagnosed Multiple Myeloma (NDMM)
Shots:
- The EC has approved Darzalex (SC) + bortezomib, lenalidomide & dexamethasone (D-VRd) to treat NDMM pts; sBLA under the US FDA’s review
- Approval was based on P-III (CEPHEUS) trial assessing D-VRd (n=197) vs VRd (n=198) in 395 ASCT-ineligible or deferred pts, in 13 countries across the EU, North & South America
- At 59mos. mFU, trial met its 1EP of overall MRD-negativity rate of 60.9% vs 39.4%, with sustained MRD-negativity rate of 48.7% vs 26.3% & showed improved PFS of 43% (mPFS: not reached vs 52.6mos.), plus overall CR or better rate of 81.2% vs 61.6%; OS data was immature. Data was presented at IMS 2024
Ref: Johnson & Johnson | Image: Johnson & Johnson
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Ridhi is an avid secondary researcher who follows trends in the biopharmaceutical and healthcare sectors to curate engaging content for the global audience. She works as a news editor at PharmaShots and loves to read books and explore new destinations.
