Sarclisa® (isatuximab) approved for the treatment of relapsed/refractory multiple myeloma in the EU1

 Almost 18,000 people in the UK live with the incurable blood cancer, multiple myeloma2  Despite current treatments relapse is common, creating an urgent need for new therapies3   This is the first anti-CD38/pomalidomide combination approved in Europe which provides significant improvement in progression-free survival4 

READING, UK – June 2, 2020 – Sanofi today 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).1 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 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.” 

Multiple myeloma is the second most common blood cancer in the UK.2 Approximately 5,700 people in the UK are diagnosed each year, equivalent to 15 people each day.2,5 

There are approximately 3,000 myeloma deaths each year, with half of patients dying within five years of diagnosis.2,5 

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.4 

“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.” 

About ICARIA-MM  The marketing authorisation is based on the results of the pivotal ICARIA-MM trial, the first randomised Phase 3 trial to report results evaluating an anti-CD38/pomalidomide combination. ICARIA-MM is an open-label, multi-centre trial evaluating isatuximab in combination with pom-dex versus pom-dex alone in patients with RRMM.4 The study enrolled 307 patients with RRMM across 96 centres spanning 24 countries, including sites in the UK.4 All patients had received a median of three prior lines of anti-myeloma therapies, including at least two consecutive cycles of lenalidomide and a proteasome inhibitor given alone or in combination.4 

About isatuximab  Isatuximab is a monoclonal antibody (known as a mAb) that binds to a specific site (epitope) on the CD38 receptor. It is designed to have multiple mechanisms of action that include programmed tumour cell death (apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on multiple myeloma cells, making it a potential target for antibody-based therapeutics such as isatuximab.4