Approvals

The Medicine and Healthcare products Regulatory Agency (MHRA) has approved quadruplet therapy, Sanofi’s SARCLISA (isatuximab) in combination to treat multiple myeloma in patients who are ineligible for a transplant.

The decision comes just days after approval from the European Commission (EC). Influenced by the results of the IMROZ study, isatuximab is now licensed in the UK as a therapy for adults with newly diagnosed multiple myeloma. The IMROZ study was a randomised multicentre, open-label phase 2 clinical study with a total patient count of 446. All patients have newly diagnosed multiple myeloma and were deemed not to be eligible for an autologous stem cell transplant.

Head of Oncology and Haematology at Sanofi UK and Ireland Anju Bhalla stated: “While significant strides have been made in multiple myeloma treatment there is a continued unmet need for patients with multiple myeloma. Effective first-line treatment is essential in managing and delaying disease progression for newly diagnosed transplant ineligible multiple myeloma patients. With today’s decision, patients across the UK are a step closer to accessing a new combination therapy. This marks a crucial milestone in our commitment to advancing multiple myeloma treatment and improving patient outcomes in the UK.”

The study monitored the safety and tolerability of isatuximab-VRd, which is the combination of isatuximab, bortezomib, lenalidomide and dexamethasone. No new safety signals were observed.

Multiple myeloma is a cancer that affects blood plasma cells. Up to 24,000 individuals in the UK suffer from the disease. There is currently no cure.