publication date: Mar. 6, 2020

Drugs & Targets

FDA approves Sarclisa in patients with previously treated MM

FDA has approved Sarclisa (isatuximab-irfc), in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.

Sarclisa, administered through intravenous infusion, is a CD38-directed cytolytic antibody that works by helping certain cells in the immune system attack multiple myeloma cancer cells.

Sanofi sponsors the drug.

FDA approved the indication based on data from ICARIA-MM (NCT02990338), a multicenter, multinational, randomized, open-label, two-arm, phase III study in 307 patients with relapsed and refractory multiple myeloma who had received at least two prior therapies including lenalidomide and a proteasome inhibitor. Patients were randomized (1:1) to receive either isatuximab-irfc with pomalidomide and low-dose dexamethasone (Isa-Pd, 154 patients) or pomalidomide and low-dose dexamethasone (Pd, 153 patients).

“Targeting cells has led to the development of important oncology treatments. While there is no cure for multiple myeloma, Sarclisa is now another CD38-directed treatment option added to the list of FDA-approved treatments of patients with multiple myeloma who have progressive disease after previous therapies,” Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, said in a statement. “In the clinical trial, there was a 40% reduction in the risk of disease progression or death with this therapy.”

The main efficacy outcome measure was progression-free survival  assessed by an independent committee based on central laboratory data for M-protein and central radiologic imaging review using International Myeloma Working Group criteria. The improvement in PFS represented a 40% … Continue reading FDA approves Sarclisa in patients with previously treated MM

To access this members-only content, please log in.
Institutional subscribers, please log in with your IP.
If you're not a subscriber why not join today?
To gain access to the members only content click here to subscribe.
You will be given immediate access to premium content on the site.
Click here to join.

Copyright (c) 2020 The Cancer Letter Inc.