20 September 2024: FDA Approves Sarclisa for First-Line Treatment of Multiple Myeloma.

The US Food & Drug Administration(FDA) approved the use of Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first-line treatment for Multiple Myeloma in newly diagnosed patients who are ineligible?for stem transplant. Sanofi received its first approval for Sarclisa in 2020 as a second-line therapy choice in Multiple Myeloma patients.

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In the phase 3 IMROZ trial, Sarclisa-VRd?reduced the risk of progression/death by 40% in the transplant-ineligible patients, when compared against VRd alone.?

The FDA approval makes Sarclisa the second CD38 antibody to be approved as a first-line treatment for myeloma. The NCCN guidelines added the Sarclisa-VRd combination, alongside VRd alone and the Darzalex-Rd combination, as Category 1 recommendations for transplant-ineligible myeloma patients.

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Sanofi is pushing for expanded indications with the GMMG-HD7 study where Sarclisa-VRd showed improved PFS?transplant-eligible newly diagnosed myeloma patients. In the recent phase 3 IsKia trial, Sarclisa, alongside Amgen’s Kyprolis, lenalidomide, and dexamethasone (KRd), enabled minimal residual disease(MRD) negativity in a higher number of transplant-eligible patients. Olivier Nataf, Sanofi’s global head of oncology, stated: “We’re getting access to the biggest segment of this market, and we are leveling the playing field in a major class of drug.”

Source: FiercePharma