FRANCE—The U.S. Food and Drug Administration (FDA) has approved Sarclisa (siltuximab) paired with bortezomib, lenalidomide, and dexamethasone (VRd) as a first-line therapeutic option for multiple myeloma (NDMM).
According to Sanofi, this drug combination is specially designed for adult patients newly diagnosed with multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).
This decision marks a significant milestone in the treatment of multiple myeloma, particularly for those not eligible for transplant.
Sarclisa is now the first anti-CD38 therapy combined with standard-of-care VRd to show a remarkable reduction in disease progression or death, decreasing these risks by 40% when compared to VRd alone in patients with NDMM.
This FDA approval also represents the third approved indication for Sarclisa in the U.S. and the first for newly diagnosed patients.
The FDA evaluated Sarclisa for this indication under Priority Review, a designation reserved for treatments that offer substantial improvements in efficacy or safety in managing serious conditions.
Sarclisa is already approved in more than 50 countries for two other indications related to relapsed or refractory disease.
The FDA’s decision was heavily based on results from the IMROZ phase 3 study, which was recently presented at the American Society of Clinical Oncology (ASCO) 2024 annual meeting and published in The New England Journal of Medicine.
IMROZ is the first global phase 3 study involving an anti-CD38 monoclonal antibody in combination with standard VRd therapy to significantly improve progression-free survival (PFS) compared to VRd alone.
In the IMROZ trial, patients who received Sarclisa-VRd followed by Sarclisa-Rd achieved the primary endpoint of PFS, reducing the risk of disease recurrence or death by 40% compared to those who received VRd followed by Rd.
Moreover, secondary endpoints from the trial showed that 74.7% of patients treated with Sarclisa-VRd achieved a complete response or better, compared to 64.1% of those on VRd alone.
The safety profile of Sarclisa was consistent with previous findings, with no new safety signals identified.
The most common side effects observed included upper respiratory tract infections, diarrhea, fatigue, peripheral sensory neuropathy, pneumonia, and other conditions such as musculoskeletal pain, cataracts, and infusion-related reactions.
Dr. Thomas Martin from the Helen Diller Family Comprehensive Cancer Center at the University of California, San Francisco, emphasized the importance of this approval.
He noted that multiple myeloma predominantly affects patients over 65, who often face limited treatment options due to age, frailty, and other health conditions.
He stressed that the approval of Sarclisa combined with VRd offers significant clinical benefits, especially in improving progression-free survival for this vulnerable patient population.
Sanofi’s Executive Vice President and Head of Specialty Care, Brian Foard, described the FDA’s approval as a significant milestone in the company’s mission to establish Sarclisa as a best-in-class therapy.
Since its initial launch in 2020, Sarclisa has made considerable strides, and this latest approval expands its reach to a broader group of patients.
Foard noted that physicians now have a new tool to help slow disease progression for patients with newly diagnosed multiple myeloma who are not eligible for a transplant.
Multiple myeloma is the second most common hematologic malignancy, affecting over 130,000 individuals in the U.S. annually, with approximately 32,000 new diagnoses each year.
Despite the availability of various treatments, it remains incurable, with a five-year survival rate of only 52% for newly diagnosed patients.
Given that most NDMM patients are not eligible for transplant, the need for new first-line therapeutic options is critical, especially as attrition rates increase with each line of therapy.
Sign up to receive our email newsletters with the latest news updates and insights from Africa and the World HERE