FDA green light for Sarclisa combo in multiple myeloma

French pharma company Sanofi has received US Food and Drug Administration (FDA) approval for its CD38 inhibitor Sarclisa in combination with carfilzomib and dexamethasone (Kd) for the treatment of advanced multiple myeloma.

The Sarclisa (isatuximab) plus Kd combination treatment is now indicated in the US for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM), who have received one to three prior lines of therapy.

In the Phase III IKEMA study, Sarclisa plus Kd reduced the risk of disease progression of death by 45% compared to standard of care Kd alone in patients with RRMM.

There was no statistically significant difference in overall response rate (ORR), which remained similar for the Sarclisa plus Kd (86.6%) and Kd alone arms (82.9%).

The complete response (CR) rate, however, was 39.7% in the Sarclisa combination therapy arm and 27.6% in the Kd arm.

“Treatment of patients with relapsed or refractory multiple myeloma remains challenging and the prognosis for patients experiencing multiple relapses unfortunately is poor,” said Peter Adamson, global development head, oncology and paediatric innovation at Sanofi.

“With this approval, Sarclisa is now included in two standard of care regimens for the treatment of patients with multiple myeloma as early as first relapse. Today’s milestone further supports our ambition for Sarclisa to become the anti-CD38 of choice for patients with relapsed or refractory multiple myeloma,” he added.

Sarclisa is also approved in the US in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adults with RRMM who have received at least two prior therapies.