Sanofi Canada announced that Health Canada has approved Sarclisa in combination with pomalidomide and dexamethasone for the treatment of adults with relapsed and refractory multiple myeloma (RRMM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
“Immunotherapies like Sarclisa leverage the immune system to fight multiple myeloma and we're seeing real progress in their ability to help patients. This was not the case over a decade ago," says Dr. Donna Reece, Clinician Investigator, and Princess Margaret Cancer Centre.
Sarclisa binds to a specific extracellular epitope of CD38 and triggers several mechanisms leading to the death of CD38-expressing tumour cells.
“For Canadian patients living with multiple myeloma, who have experienced a return of their disease or become resistant to prior treatments, it's vital to have new options like Sarclisa,” says Marissa Poole, Country Lead, Canada and general manager, Sanofi Genzyme. “At Sanofi Genzyme we remain committed to developing innovative medicines that can make a significant difference in patients' lives. Sarclisa has the potential to offer a new standard of care, and we continue to evaluate Sarclisa in a comprehensive clinical program in multiple myeloma, as well as in other blood cancers and solid tumours.”
“We encourage patients to play an active role in treatment decisions. But every patient is different – their life goals, their disease, and the care they require. We must continue to advocate for them and improve their access to the therapies they need,” says Martine Elias, executive director, Myeloma Canada. “The research in myeloma has been promising. We're seeing new therapies, like Sarclisa, becoming available to more patients. Every new treatment is a move in the right direction to help patients live longer and better lives and continue to deliver hope.”
Relapsed (or recurrent) multiple myeloma means that the cancer returns after treatment or a period of remission. Since multiple myeloma does not have a cure, most patients will relapse at some point. Refractory multiple myeloma refers to cancer that does not respond to therapy.
The approval of Sarclisa by Health Canada was based on the ICARIA-MM study. Sarclisa added to pom-dex (SARCLISA combination therapy) demonstrated a statistically significant improvement in progression-free survival (PFS) with a median PFS of 11.5 months compared to 6.5 months with pom-dex alone (HR 0.596, 95% CI: 0.44-0.81, p=0.0010). Sarclisa combination therapy also demonstrated a significantly greater overall response rate compared to pom-dex alone (60.4% vs. 35.3%, p<0.0001).
The most common adverse reactions (occurring in >20% of patients) in patients who received Sarclisa combination therapy were infusion-related reactions (38%), pneumonia (31%), upper respiratory tract infections (28%) and diarrhea (26%). Abnormal hematological laboratory results were evident in patients who received Sarclisa combination therapy, including neutropenia (96%) and febrile neutropenia (12%). Permanent discontinuation of Sarclisa combination therapy due to an adverse reaction (Grades 3-4) occurred in 7% of patients and 3% of patients discontinued due to an infusion-related reaction.
Sarclisa is to be administered as an intravenous (IV) infusion at 10 mg/kg, in combination with pom-dex, every week for four weeks and then every two weeks, until disease progression or unacceptable toxicity.
Sarclisa continues to be evaluated in multiple ongoing phase 3 clinical trials.
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