Sanofi has announced that the European Commission (EC) has authorised Sarclisa® (isatuximab) for use in combination with existing standard of care treatment (pomalidomide and low-dose dexamethasone, or pom-dex) in adults with relapsed/refractory multiple myeloma (RRMM).
This approval was based on positive data from the Phase 3 ICARIA-MM trial and follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on 26 March, 2020. Sanofi is working closely with healthcare providers and organisations in the UK to make isatuximab available to patients as quickly as possible.
Multiple myeloma is the second most common blood cancer in the UK. Approximately 5,700 people in the UK are diagnosed each year, equivalent to 15 people each day.
There are approximately 3,000 myeloma deaths each year, with half of patients dying within five years of diagnosis.
In the ICARIA-MM trial, isatuximab in combination with pom-dex significantly reduced the risk of disease progression or death in adults by 40%, with a median PFS of 11.5 months compared to 6.5 months with pom-dex alone (HR 0.596, 95% CI: 0.44-0.81, p=0.001). Overall, isatuximab showed an additional five months of progression-free survival.
“Multiple myeloma is an incurable, fatal cancer, with high mortality that affects thousands of people in the UK every year,” said Professor Kwee Yong, Consultant of Haematology, University College Hospital, London.
“Patients with relapsed/refractory disease experience great emotional distress and a decline in quality of life due to frequent relapses. The disease can also become more aggressive after each relapse, and resistant to previous therapies. The approval of isatuximab is hugely welcomed among the medical community as it offers the chance of prolonged disease control, improving patients’ lives and wellbeing.”
“MM is a complex and progressive disease that contributes to an increasing number of deaths in the UK each year. Isatuximab binds to a specific part of the CD38 protein and is able to combine with other treatments to improve the magnitude of the therapeutic response,” said Dr Marc Moodley, Medical Director, Sanofi Genzyme. “The approval of isatuximab by the European Commission is excellent news and we are proud to be able to bring isatuximab to patients who need new treatment options.”