Johnson & Johnson Submits sBLA of Darzalex Faspro Regimen to the US FDA for Newly Diagnosed Multiple Myeloma Patients
Shots:
- J&J has submitted sBLA of Darzalex Faspro combined with bortezomib, lenalidomide & dexamethasone (D-VRd) to treat newly diagnosed multiple myeloma in patients deferred to or ineligible for ASCT
- Submission was based on the P-III (CEPHEUS) trial assessing the safety & efficacy of D-VRd vs VRd in NDMM patients (n=396) with unplanned ASCT as initial therapy, across 13 regions
- Study improved the durability of responses, achieving overall MRD-negativity rate of 60.9% vs 39.4% (at median follow-up of 58.7mos.) with sustained MRD-negativity rate of 48.7% vs 26.3%, reduction in the risk of progression or death by 43% and overall CR or better rate of 81.2% vs 61.6%. Safety aligned with known profile of Darzalex Faspro & VRd
Ref: PR Newswire | Image: Johnson & Johnson
Related News: Johnson & Johnson’s Darzalex Faspro Quadruplet Combination Gains the US FDA’s Approval to Treat Multiple Myeloma (MM)
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
Click here to read the full press release
Tags
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.
