Sanofi’s Sarclisa combo approved in Europe for relapsed/refractory multiple myeloma
pharmafile | June 2, 2020 | News story | Manufacturing and Production, Sales and Marketing | Europe, Sanofi, Sarclisa, pharma
Sanofi has scored a new approval from the European Commission for the use of its CD38 inhibitor Sarclisa (isatuximab) in the treatment of relapsed or refractory multiple myeloma when combined with Pomalidomide and dexamethasone (pom-dex).
The approval in European Union member states relates specifically to adults who have previously treated at least twice for the condition, including with lenalidomide and a proteasome inhibitor, and have seen their disease progress since they were last treated.
The new Phase 3 data revealed that the Sarclisa combo recorded a median progression-free survival of 11.53 months in patients, demonstrating a statistically significant improvement over the median 6.47 months achieved with pom-dex alone.
The results also showed an overall response rate of 60.4% for the Sarclisa combo compared to 35.5% with pom-dex monotherapy.
Sanofi added that these benefits were shown in additional analyses to be consistent across “select sub-groups reflective of real-world practice”, including patients over the age of 75, with renal insufficiency or high-risk cytogenetics, or those who were refractory to treatment with lenalidomide.
“The EC approval of Sarclisa represents an important additional therapeutic option and may set a new standard of care for myeloma patients in Europe who are in need of new effective treatments because their disease has returned or they have become refractory to their previous treatment,” commented Dr John Reed, Global Head of Research and Development at Sanofi. “Sarclisa in combination with pom-dex demonstrated median progression-free survival of nearly one year, a five-month improvement over pom-dex alone, in patients who had already failed at least two prior therapies.”
Matt Fellows
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