Sanofi’s Sarclisa (isatuximab) Receives EC’s Approval for adults with Relapsed and Refractory Multiple Myeloma

Shots:

• EC’s approval is based on P-III ICARIA-MM study assessing Sarclisa + (pomalidomide and dexamethasone) pom-dex vs pom-dex as monothx. for patients with r/r MM, prior treated with at least two therapies including lenalidomide and a proteasome inhibitor with progression on the last therapy
• Results: mPFS (11.53 vs 6.47mos.); OS (60.4% vs 35.3%); In an additional analysis, the therapy showed benefits in patients with high risk cytogenetics, those aged ≥75yrs. with renal insufficiency and who were refractory to lenalidomide. The EC’s MAA for Sarclisa is applicable EU’s 27 states in addition to the UK, Iceland, Liechtenstein and Norway
• Sarclisa is mAb targeting CD38 receptor on MM cells, act by inducing apoptosis & immunomodulatory activity and has received FDA’s approval on Mar 02, 2019. The company continues to evaluate Sarclisa in P-III clinical studies in combination with current standard treatments across the MM treatment continuum

Click here ­to­ read full press release/ article | Ref: Sanofi | Image: StraitTimes