Sanofi Gains Approval for Sarclisa in Multiple Myeloma, Set to Compete With J&J

The FDA recently approved Sanofi’s Sarclisa (isatuximab) for the treatment of newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplantation. This decision positions Sarclisa in direct competition with Johnson & Johnson’s Darzalex, the first anti-CD38 monoclonal antibody for multiple myeloma, which generated nearly $10 billion in revenue last year.

Sarclisa is now authorized for first-line treatment in conjunction with the standard care protocol involving bortezomib, lenalidomide, and dexamethasone (VRd). According to Sanofi, Sarclisa is the first anti-CD38 therapy to significantly diminish disease progression or death when combined with the VRd regimen.

Brian Foard, Sanofi’s Head of Specialty Care, described the approval as a “momentous milestone” toward establishing Sarclisa as a leading therapy. Foard emphasized that this new indication provides doctors with a critical option that extends disease progression compared to the current standard care.

Sanofi is also pursuing further development for Sarclisa, conducting several Phase II and Phase III studies for six potential indications within the multiple myeloma treatment spectrum. Additionally, the company is working on a subcutaneous formulation for Sarclisa.

The FDA approval was supported by results from the Phase III IMROZ study, which demonstrated that the Sarclisa regimen reduced the risk of recurrence or death by 40% compared to the VRd and Rd regimen alone. This result was statistically significant with a p-value of 0.0009. After nearly 60 months of follow-up, the median progression-free survival had not been reached in the Sarclisa treatment group.

Sarclisa also excelled in secondary endpoints in the IMROZ study, with almost 75% of patients achieving complete response or better, compared to 64.1% in the comparator group. Regarding safety, the study reported no new concerns. The most common adverse events included respiratory tract infections, pneumonia, fatigue, muscle pain, constipation, diarrhea, insomnia, and infusion-related reactions. Over 70% of patients in the Sarclisa group experienced serious adverse events.

With this approval, Sarclisa will challenge Johnson & Johnson’s Darzalex, which is well-established in the multiple myeloma market. Darzalex generated around $10 billion in revenue in 2023, reflecting a 22% year-on-year sales increase. Darzalex also has a subcutaneous version known as Darzalex Faspro, initially approved in 2020 for multiple myeloma. In July 2024, Faspro received another approval for use in newly diagnosed multiple myeloma patients eligible for transplantation.