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Sanofi Canada receives Health Canada approval for Sarclisa in combo with carfilzomib & dexamethasone for r/r refractory multiple myeloma

Mississauga, Ontario
Thursday, October 14, 2021, 15:00 Hrs  [IST]

Sanofi Canada is announced 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.

"The approval of this new Sarclisa combination therapy gives HCPs another treatment option that can be integrated at first relapse," said Scott Strong, oncology franchise head at Sanofi Genzyme Canada. "Because most patients will experience a relapse at some point, it is important to deliver the best possible outcomes early in treatment courses. Every patient is unique, and this new indication means Sarclisa has the potential to benefit a wide variety of Canadians living with multiple myeloma."

This approval marks the second indication for Sarclisa in combination with a standard of care regimen for the treatment of relapsed and/or refractory MM. Previously, Sarclisa received Health Canada approval in combination with another standard of care regimen, pomalidomide and dexamethasone (Pd), for the treatment of adult patients with relapsed and refractory MM who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. Sarclisa is the first and only anti-CD38 antibody in combination with Pd to be approved in Canada.

"Patients in the IKEMA trial had a number of challenging characteristics, with almost one third being refractory to lenalidomide at study entry. Despite these obstacles, the addition of isatuximab to Kd resulted in a 47% reduction in the risk of disease progression and death, and the benefit was evident across all patient subgroups. These findings strengthen our confidence in isatuximab in the relapsed and refractory setting and demonstrate that isatuximab is becoming a standard of care in this environment," said Donna Reece, MD, FRCPC, senior hematologist who cares for myeloma patients.

Despite available treatments, MM remains an incurable malignancy, and is associated with significant patient burden. Since MM does not have a cure, most patients will relapse. Relapsed MM is the term for when the cancer returns after treatment or a period of remission. Refractory MM refers to when the cancer does not respond or no longer responds to therapy.

"Triplet therapies are being used more frequently as we learn more about the most effective and safe treatment options for patients with multiple myeloma. Anti-CD38 antibodies like Sarclisa have demonstrated a significant improvement in patient outcomes and continue to move into earlier lines of therapy. The availability of this second indication for Sarclisa provides another therapeutic option for patients as early as their first relapse, which is a critical point in the treatment journey,"said Martine Elias, MSc, executive director, Myeloma Canada.

This Health Canada approval was based on data from the phase 3 IKEMA study, a randomized, multicentre, open-label clinical trial that enrolled 302 patients with relapsed MM across 69 centres spanning 16 countries. The primary endpoint of IKEMA was progression-free survival (PFS). Secondary endpoints of the IKEMA trial included overall response rate (ORR), complete response (CR) and very good partial response (VGPR).

Sarclisa is a monoclonal antibody that binds to a specific extracellular epitope of CD38 and triggers several mechanisms leading to the death of CD38-expressing tumour cells. CD38 is a transmembrane glycoprotein with ectoenzymatic activity, expressed in hematological malignancies, including MM cells, as well as other cell types and tissues at various levels.

Sarclisa continues to be evaluated in multiple ongoing phase 3 clinical trials in combination with current standard treatments across the MM treatment continuum. It is also under investigation for the treatment of other hematologic malignancies and solid tumours. The safety and efficacy of these additional uses have not been reviewed by any regulatory authority worldwide.


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