Sanofi's Sarclisa Approved for Newly Diagnosed Multiple Myeloma Patients

Sanofi, despite largely withdrawing from the oncology sector, continues to benefit from its multiple myeloma treatment, Sarclisa. The FDA recently approved Sarclisa as a first-line treatment for patients with newly diagnosed multiple myeloma who are ineligible for an autologous stem cell transplant. This makes Sarclisa the sole CD38 inhibitor that has demonstrated a reduction in the risk of death when combined with the standard treatment regimen known as VRd, which includes Velcade, Revlimid, and dexamethasone, compared to the standard treatment alone.

This approval is significant as it marks the third endorsement for Sarclisa and the first for newly diagnosed patients. The FDA initially approved Sarclisa in March 2020 for patients with relapsed or refractory multiple myeloma as a third-line treatment. Brian Foard, Sanofi's head of specialty care, expressed pride in the progress made since Sarclisa's launch in establishing it as a top-tier therapy.

The basis for the FDA’s decision stems from Sanofi’s Phase 3 clinical data, which indicated that the estimated progression-free survival rate at five years was 63.2% for patients treated with Sarclisa in conjunction with VRd, compared to 45.2% for those who received the standard treatment alone. Additionally, nearly 75% of patients on Sarclisa achieved a complete response or better, compared to 64.1% of patients who were not on the treatment.

The safety profile from the trial was consistent with known side effects of Sarclisa and VRd. Pneumonia was the most common serious adverse event, occurring in 30% of patients receiving Sarclisa, though more patients discontinued treatment due to side effects in the VRd-only group than in the Sarclisa group.

Sanofi is continuing to explore Sarclisa's potential through various mid-to-late stage studies across six multiple myeloma indications and is also evaluating a subcutaneous version of the drug. Market performance has been strong, with Sarclisa generating €227 million ($253 million) in revenue in the first half of the year, marking a 32% increase compared to the same period in the previous year.

Despite Sarclisa’s early success and ongoing regulatory approvals, Sanofi has strategically decided to de-emphasize oncology in its R&D investments. Houman Ashrafian, Sanofi’s head of R&D, indicated during a company presentation last year that while Sanofi has the capability to succeed in oncology, the focus will be more targeted.

Consequently, Sanofi enacted a comprehensive restructuring of its R&D strategy earlier this year. This restructuring included scaling back certain oncology-focused partnerships and early-stage assets. Additionally, Sanofi sold three T cell engager programs acquired from Amunix to Vir Biotechnology, a transaction that was finalized earlier this month.