The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of ’s Sarclisa combined with Velcade, plus Revlimid, plus dexamethasone (VRd) for treating newly diagnosed multiple myeloma (MM). This combination is intended for individuals who are not eligible for autologous stem cell transplants. The gold standard of business intelligence.
The CHMP’s decision was influenced by the outcomes of the global Phase III IMROZ trial, which evaluated Sarclisa combined with VRd and VRd alone in enhancing progression-free survival. The therapy, which includes mechanisms such as apoptosis and immunomodulatory activity, has been approved in more than 50 countries for certain adult patients with relapsed or refractory MM. Additionally, its safety profile, when combined with VRd, was found to align with previous findings, exhibiting no new safety concerns.
Sanofi development global head and chief medical officer Dietmar Berger said: “The positive CHMP opinion is an important step forward for people with transplant-ineligible newly diagnosed multiple myeloma for whom effective front-line therapy may improve long-term outcomes. Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research.
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