Johnson & Johnson Reports Type II Variation Application Submission to the EMA for Darzalex as a Treatment of Multiple Myeloma
Shots:
- The submission was based on the P-III (PERSEUS) trial assessing the safety and efficacy of Darzalex (SC) + bortezomib, lenalidomide (R) & dexamethasone (D-VRd) followed by Darzalex-lenalidomide (D-R) maintenance vs VRd followed by R maintenance to treat newly diagnosed multiple myeloma adults (n=709) eligible for ASCT
- The trial achieved PFS (1EP), showing a 58% reduced disease progression or death risk at 47.5mos. of median follow-up duration & an increase in depth of response, with high CR rates, stringent CR (sCR) & MRD negativity
- Furthermore, 64% of patients, entering the maintenance phase in the D-VRd cohort, discontinued Darzalex after attaining a CR or better & MRD negativity for 12+ mos. following ~2yrs. of D-R maintenance
Ref: Johnson & Johnson | Image: Johnson & Johnson
Related News:- Janssen Presents Efficacy and Subgroup Analyses from P-III Study (MAIA) Results of Darzalex for Multiple Myeloma at ASH 2022
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
