Days after the European Commission (EC) granted approval, the UK’s Medicines and Healthcare Regulatory Agency (MHRA) has approved Sarclisa (isatuximab) alongside bortezomib, lenalidomide, and dexamethasone (VRd), for newly-diagnosed multiple myeloma patients (NDMM) ineligible for autologous stem cell transplant (ASCT).
The MHRA approval, based on the IMROZ Phase III study, makes the Sanofi (Euronext: SAN) product the first and only anti-CD38 quadruplet therapy for the transplant ineligible newly diagnosed multiple myeloma population in the UK.
Sarclisa, in combination with VRd, will now undergo evaluation from the cost-effectiveness body for England and Wales, the National Institute of Health and Care Excellence (NICE), to determine whether it represents good value and will therefore be reimbursed on the National Health Service.
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