Sanofi’s Sarclisa approved for the treatment of transplant-eligible newly diagnosed multiple myeloma in the EU

Sanofi announces that the European Commission has approved Sarclisa in combination with bortezomib, lenalidomide and dexamethasone for the induction treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.

“We have been on a mission to accelerate Sarclisa’s clinical development program with the hope to bring this important medicine to as many people as possible living with multiple myeloma,” said Olivier Nataf, Global Head of Oncology at Sanofi. “Today’s decision represents a prime example of those efforts, and most importantly, paves the way for Sarclisa to potentially become accessible to even more patients in the EU, regardless of transplant eligibility or line of therapy.”

Note that this approval is based on results from part one of the two-part, double-randomized, German-speaking Myeloma Multicenter Group-HD7 phase 3 study, which was designed to independently assess the effects of Sarclisa during the induction and maintenance phases. Sarclisa-VRd demonstrated a deep and rapid response in transplant-eligible NDMM patients compared to VRd alone, reflected by a statistically significant minimal residual disease negativity benefit at the end of the 18-week induction period, which was the primary endpoint of part one.

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Related Topics and Keywords

multiple myeloma, Sanofi, Sarclisa®