Sanofi Canada is pleased to announce that Health Canada has approved SARCLISA® in combination with carfilzomib and dexamethasone (Kd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.

SARCLISA is a CD38-directed cytolytic antibody indicated:...in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor...in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.

Sarclisa is indicated, in combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor (PI) and have demonstrated disease progression on the last therapy.

SARCLISA is a CD38-directed cytolytic antibody indicated, 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.

THERAPY FOR PREVIOUSLY TREATED MULTIPLE MYELOMA...Isatuximab-irfc/carfilzomib/dexamethasone (category 1)

Isatuximab, plus pomalidomide and dexamethasone, is recommended for use within the Cancer Drugs Fund as an option for treating relapsed and refractory multiple myeloma in adults who have had lenalidomide and a proteasome inhibitor, and whose disease has progressed on their last treatment...

Multiple Myeloma: Therapy for previously treated multiple myeloma…Other Recommended Regimens… Isatuximab-irfc/carfilzomib/dexamethasone

The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for the investigational use of Sarclisa (isatuximab) in combination with bortezomib, lenalidomide and dexamethasone (VRd) for the treatment of patients with transplant-ineligible newly diagnosed multiple myeloma (NDMM).

Consistent with the primary interim analysis, the addition of Isa to Kd prolonged PFS (HR 0.58, 95.4% CI: 0.42-0.79; median PFS 35.7 [95% CI: 25.8-44.0] vs 19.2 [95% CI: 15.8-25.0] months). PFS benefit was observed with Isa-Kd across subgroups, including patients with poor prognosis...These findings further support Isa-Kd as a standard-of-care treatment for relapsed multiple myeloma patients.

The addition of isatuximab to carfilzomib–dexamethasone significantly improves progression-free survival and depth of response in patients with relapsed multiple myeloma.

CHMP recommends approval of Sarclisa® (isatuximab) in combination with carfilzomib and dexamethasone for the treatment of relapsed multiple myeloma...Recommendation based on data from Phase 3 IKEMA study in which Sarclisa combination therapy demonstrated a statistically significant improvement of progression free survival compared to standard of care carfilzomib and dexamethasone...

Median PFS was 11.53 months with Isa-Pd and 6.47 months with Pd (hazard ratio [HR] 0.596; 95% confidence interval [CI] 0.436-0.814). Tumor responses on Isa-Pd were more frequent and deeper than on Pd. Overall response rates (ORR) were 60.4% vs 35.3% (odds ratio [OR] 2.80; 95% CI 1.72-4.56; p<0.0001); at least very good partial response rates (≥VGPR) were 31.8% vs 8.5% (OR 5.03; 95% CI 2.51-10.59;

In this Phase 3 study (NCT03275285), pts with RRMM and 1-3 prior lines of therapy were randomized 3:2 and stratified by number of prior lines and R-ISS to receive Isa-Kd or Kd….PFS benefit was consistent across subgroups. ORR (≥partial response [PR]) was 86.6% Isa-Kd vs 82.9% Kd, one-sided p=0.1930....Addition of Isa to Kd provided a superior, statistically significant improvement in PFS with clinically meaningful improvement in depth of response.