Isatuximab Now FDA Approved with Kyprolis and Dex for Relapsed/Refractory Myeloma

This week the FDA approved the use of the anti-CD38 monoclonal antibody isatuximab (Sarclisa) in combination with carfilzomib (Kyprolis) and dexamethasone for relapsed or refractory myeloma patients who received 1-3 prior therapies. 

The approval was based on the Phase III IKEMA trial which showed that IsaKd triple combination reduced the risk of myeloma progression or death by 45% compared to Kd alone. The study has not yet met the median progression-free survival at the time of study reporting.

The study also showed the following results: 

Most common side effects were: 

The most serious side effects in the isatuximab combination therapy arm were pneumonia (25%) and upper respiratory tract infections (9%).

Thomas Martin, MD and associate director and co-leader of the Hematopoietic Malignancies Program of the myeloma program at the University of California San Francisco (UCSF) said: 

“In the Phase 3 IKEMA study, the addition of Sarclisa to carfilzomib and dexamethasone reduced risk of disease progression or death by 45%. This approval is an important advancement for patients whose disease has relapsed and reinforces the potential for Sarclisa to become a standard of care in relapsed or refractory multiple myeloma.” 

Isatixumab was previously approved for use with pomalidomide and dexamethasone who had received at least two prior therapies (including lenalidomide and a proteasome inhibitor.)