Shots:
- The US FDA has approved Darzalex FASPRO (daratumumab and hyaluronidase-fihj) + bortezomib, lenalidomide & dexamethasone (D-VRd) for adults with NDMM who are ineligible for autologous stem cell transplant.
- Approval was based on the P-III (CEPHEUS) trial, assessing D-VRd vs VRd in 395 ASCT-ineligible or deferred patients across 13 countries in the EU, North America, and South America.
- At 22 mos. mFU, CEPHEUS showed higher MRD-negativity with D-VRd vs VRd (52.3% vs 34.8%). At 39 mos. mFU, sustained MRD-negativity ≥12 mos. nearly doubled (42.6% vs 25.3%) with a 40% reduction in risk of progression or death. At 59 mos. mFU, D-VRd achieved deeper responses with CR or better rates of 81.2% vs 61.6%; OS data were immature
Ref: Johnson & Johnson | Image: Johnson & Johnson | Press Release
Related News: Johnson & Johnson’s Tremfya (Guselkumab) Receives the EC Approval for Pediatric Plaque Psoriasis (PsO)
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