French pharmaceutical company Sanofi has received Japan’s Ministry of Health, Labour and Welfare (MHLW) approval for Sarclisa plus VRd to treat a type of multiple myeloma.
VRd refers to a combination of bortezomib, lenalidomide, and dexamethasone.
Sarclisa (isatuximab) is a monoclonal antibody that binds to a specific epitope on the CD38 receptor on multiple myeloma (MM) cells, inducing distinct antitumor activity.
The drug is designed to work through multiple mechanisms of action including programmed tumour cell death (apoptosis) and immunomodulatory activity.
Sarclisa is indicated for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) based on data from the Phase 3 IMROZ clinical study.
In the Phase 3 study, Sarclisa plus VRd significantly improved progression-free survival, compared to VRd alone in treating NDMM.
Sanofi oncology global head Olivier Nataf said: “In recent years, new multiple myeloma cases have increased steadily in Japan and other Asian-Pacific nations, creating a need for new treatment approaches, particularly in the front-line setting.
“While Sarclisa-based combinations have been approved for relapsed or refractory patients in Japan, this approval represents the first indication for certain newly diagnosed patients.
“We are pleased to offer physicians an important new option for their patients earlier in the treatment journey, building upon our continued commitment to advancing innovative oncology treatments in difficult-to-treat hematologic malignancies around the world.”
Currently, Sarclisa is approved in more than 50 countries, including the US, EU, Japan, and China, as monotherapy and as a combination regimen, across multiple indications.
Sarclisa was introduced in Japan in August 2020 and has been approved for four different treatment regimens to treat patients with relapsed or refractory multiple myeloma.
Earlier this year, China’s National Medical Products Administration approved Sarclisa-VRd combination and Sarclisa plus pomalidomide and dexamethasone (Pd).
Sanofi plans to continue developing Sarclisa as part of a patient-centric clinical development programme, comprising several Phase 2 and Phase 3 studies in six potential indications.
In addition, the company is evaluating a subcutaneous (SC) administration method for Sarclisa in clinical studies.
Last month, Sanofi announced positive results from the Phase 3 IRAKLIA study of Sarclisa plus Pd in SC formulation, administered via an on-body delivery system (OBDS).
