Sarclisa Receives New Indication for Relapsed or Refractory Multiple Myeloma

March 31, 2021 – The U.S. FDA has approved a new indication for Sarclisa® (isatuximab), manufactured by Sanofi. The drug is now indicated for use in combination with carfilzomib and dexamethasone to treat relapsed or refractory multiple myeloma (RRMM) in adults who have received one to three prior lines of therapy.

Multiple myeloma occurs when plasma cells – a type of white blood cell responsible for creating antibodies to fight infection – become cancerous. The affected plasma cells weaken the immune system, leaving less room for the development of healthy immune cells and producing an abnormal protein that harms healthy tissues. Relapsed or refractory multiple myeloma occurs when the disease either returns following treatment or doesn’t respond to treatment. RRMM generally has poor clinical outcomes and a low survival rate.

In a clinical trial, Sarclisa plus carfilzomib and dexamethasone (Kd) reduced risk of disease progression or death by 45% compared to treatment with Kd alone. Recommended dosing for Sarclisa is 10mg/kg of the patient’s body weight, administered via intravenous infusion every week for four weeks, then every two weeks until disease progression or unacceptable toxicity occur.

Originally FDA approved in 2020, Sarclisa is also indicated for use in combination with pomalidomide and dexamethasone to treat multiple myeloma in patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.