Sanofi’s Sarclisa (isatuximab) has been approved by the Medicines and Healthcare product Regulatory Agency (MHRA) as part of a combination treatment for newly diagnosed multiple myeloma (MM).
The regulator has approved the drug for use alongside standard-of-care bortezomib, lenalidomide and dexamethasone (VRd) to treat adults who are ineligible for autologous stem cell transplant (ASCT).
An estimated 5,900 new cases of MM, an incurable cancer of the blood plasma cells, are diagnosed in the UK every year.
Administered as an intravenous infusion, Sanofi’s Sarclisa is designed to bind to the CD38 protein on MM cells and induce distinct anti-tumour activity.
The MHRA’s decision on the anti-CD38 quadruplet therapy, which comes less than a week after the European Commission approved the Sarclisa combination for the same patient population, was based on positive results from the phase 3 IMROZ trial.
The open-label trial achieved its primary endpoint, with Sarclisa plus VRd followed by Sarclisa and Rd reducing the risk of disease progression or death by 40% compared to VRd followed by Rd.
Median progression-free survival (PFS) with the Sarclisa/VRd combination was not reached after a median follow up of 59.7 months versus 54.3 months with VRd, and the estimated PFS at 60 months was 63.2% for patients randomised to receive Sarclisa/VRd compared to 45.2% for the VRd cohort.
Benefits were also seen across the study’s secondary endpoints, and the safety and tolerability of the combination was consistent with the known safety profile of each agent.
Sarclisa/VRd in this indication will now be evaluated by the National Institute for Health and Care Excellence to determine whether it will be reimbursed for use on the NHS.
Anju Bhalla, head of oncology and haematology at Sanofi UK and Ireland, said: “While significant strides have been made in MM treatment there is a continued unmet need for patients with MM. Effective first-line treatment is essential in managing and delaying disease progression for newly diagnosed transplant ineligible MM patients.
“With [the MHRA’s] decision, patients across the UK are a step closer to accessing a new combination therapy.”
The Sarclisa combination has also already been approved by the US Food and Drug Administration to treat newly diagnosed MM in adults ineligible for ASCT.