Sanofi's Sarclisa Approved by FDA, Competes with J&J's Darzalex in $15B Market

Since its initial approval by the U.S. Food and Drug Administration (FDA) in 2020, Sarclisa, produced by Sanofi, has been prescribed specifically to treat patients with multiple myeloma who have previously received other treatments. This changed recently when the FDA approved Sarclisa for use in combination with Bortezomib, lenalidomide, and dexamethasone (VRd) for treating newly diagnosed multiple myeloma patients who are not eligible for stem cell transplantation.

This expanded approval positions Sarclisa to compete more directly with Johnson & Johnson's Darzalex. Since 2018, Darzalex has been the only CD38 antibody approved for first-line myeloma treatment. Darzalex received FDA approval for use in combination with Bortezomib, Mefaran, and prednisone, particularly for patients who are not candidates for transplantation. However, the method of use for Darzalex is now considered outdated and less commonly applied.

Before this latest FDA approval, the Sarclisa-VRd combination had recently been included in the National Comprehensive Cancer Network (NCCN) myeloma treatment guidelines as a preferred protocol for patients who cannot undergo transplantation. This put it on par with VRd therapy alone and the Darzalex-Rd combination, all of which are listed as Category I recommendations.

Olivier Nataf, Sanofi's global head of oncology, expressed confidence in the new approval's impact, noting that it enters Sarclisa into the largest segment of the market and enhances competition in a significant drug category.

The efficacy of Sarclisa-VRd was demonstrated in the Phase III IMROZ trial. This trial showed that compared to VRd alone, the Sarclisa protocol significantly reduced the risk of disease progression or death by 40% in newly diagnosed patients who are ineligible for transplantation. In the study, patients in the VRd group remained free from disease progression for an average of 54.3 months. While Sarclisa’s median progression-free survival (PFS) was not reached at the time of analysis, researchers estimated it at about 90 months.

In comparison, Darzalex-Rd achieved a median PFS of 61.9 months, significantly higher than the 34.4 months observed with Rd alone, based on the latest analysis of the Phase 3 MAIA trial in newly diagnosed patients who were not suitable for transplantation.

Despite Darzalex's strong market presence, with Johnson & Johnson reporting a 22% increase in global sales to $9.7 billion in 2023, Sanofi’s Sarclisa has also shown significant growth. Sarclisa's revenue reached $381 million last year, marking a 30% increase from the previous year. Nataf remains optimistic about Sarclisa's market potential, citing estimates that the CD38 class could generate annual revenues of $15 billion by 2028.

Sanofi’s Sarclisa-VRd regimen for transplant-ineligible patients is Sanofi’s first foray into first-line treatment, but the company is aiming for broader indications. Sanofi announced in August that Sarclisa combined with VRd significantly improved PFS in newly diagnosed myeloma patients eligible for transplant, based on results from the German GMMG-HD7 study. Sanofi plans to seek regulatory approval in the U.S. in the first half of 2025, with the NCCN guidelines already listing this combination as an “alternative recommendation” for first-line transplant candidates, while Darzalex-VRd remains the preferred option.

Further, Sarclisa is being evaluated in combination with Amgen's Kyprolis, lenalidomide, and dexamethasone. In the IsKia Phase 3 clinical trial, the Sarclisa-KRd regimen significantly aided more transplant-eligible patients in achieving deep tumor clearance, defined as minimum residual disease-negative status. Although regulatory plans for this application have not been disclosed, the FDA may consider minimal residual disease as an alternative endpoint to expedite new myeloma therapies' approval, supported by advisory committee experts who unanimously recommended this approach based on past clinical trials showing it predicts long-term outcomes like PFS.