The FDA has accepted a Biologics License Application (BLA) for isatuximab for the treatment of patients with relapsed/refractory multiple myeloma, according to Sanofi, the manufacturer of the anti-CD38 monoclonal antibody.
Isatuximab was administered intravenously (IV) at 10 mg/kg once weekly for 4 weeks followed by bi-weekly for 28-day cycles in combination with standard pomalidomide and dexamethasone for the duration of therapy. There were 154 patients on the isatuximab arm and 153 patients on the control arm of Pd alone. Treatment was continued until disease progression or unacceptable toxicity. The primary endpoint was PFS. Key secondary endpoints included overall response rate (ORR) and OS.
The PFS results per investigator assessment were similar to the independent review data. The investigator data showed a median PFS of 11.14 months with the isatuximab triplet compared with 6.54 months for the Pd-alone group (HR, 0.602; 95% CI, 0.444-0.816; P
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