Sanofi has announced the approval of Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone for the induction treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are eligible for autologous stem cell transplant in the EU. This milestone follows positive feedback from the European Medicines Agency’s Committee for Medicinal Products for Human Use. The decision underscores Sanofi’s commitment to expanding access to Sarclisa for multiple myeloma patients.
The approval is based on the impressive results from the GMMG-HD7 phase 3 study, showcasing Sarclisa’s efficacy in inducing deep and rapid responses in transplant-eligible NDMM patients. The study’s findings, including significant minimal residual disease negativity benefits and improved progression-free survival rates, highlight the potential of Sarclisa-VRd as a front-line treatment option. With Sarclisa already approved in over 50 countries for multiple myeloma across various treatment lines, including in the US, EU, Japan, and China, this latest approval further solidifies its position as a valuable therapy in the fight against this challenging disease.
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