Sanofi Reports the US FDA’s sBLA Acceptance of Sarclisa to Treat Transplant-Ineligible Newly Diagnosed Multiple Myeloma
Shots:
- Sanofi’s sBLA of Sarclisa + bortezomib, lenalidomide & dexamethasone (VRd) to treat transplant-ineligible newly diagnosed multiple myeloma (NDMM) has been accepted & granted priority by the US FDA with its decision expected on Sep 27, 2024. Another submission is under review across the EU
- The sBLA was based on the P-III (IMROZ) trial assessing Sarclisa (10mg/kg, IV, QW for 5wks. during the first 42-day cycle; Q2W in C2 to C4) + bortezomib (SC), lenalidomide (oral) & dexamethasone (IV) to treat transplant-ineligible MM patients (n=446)
- The study met the 1EP during efficacy interim analysis, showing improved PFS as well as a consistent safety profile & tolerability. Results will be highlighted at ASCO & EHA 2024
Ref: Globenewswire | Image: Sanofi
Related News:- Sanofi Announces the Result of Sarclisa (isatuximab)+ KRd in P-III Trial to Treat Multiple Myeloma
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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.
