PARIS (dpa-AFX) - French drug major Sanofi S.A. (SNYNF,SNY) announced Monday that Sarclisa (isatuximab) has been recommended for European Union approval by the Committee for Medicinal Products for Human Use or CHMP to treat transplant-eligible newly diagnosed multiple myeloma, based on GMMG-HD7 phase 3 study results. A final decision is expected in the coming months.
The European Medicines Agency's CHMP has adopted a positive opinion recommending the approval of Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the induction treatment of adult patients with newly diagnosed multiple myeloma or NDMM, who are eligible for autologous stem cell transplant.
The positive CHMP opinion is based on part one results from the two-part, double-randomized, German-speaking Myeloma Multicenter Group (GMMG)-HD7 study. The results were presented at the 2024 American Society of Hematology Annual Meeting & Exposition and published in the Journal of Clinical Oncology.
The company noted that GMMG-HD7 is the first phase 3 study to demonstrate a deep and rapid response with an anti-CD38-based induction regimen in transplant-eligible (TE) NDMM patients.
Olivier Nataf Global Head, Oncology, said, 'The CHMP's recommendation represents significant progress toward our ambition for Sarclisa, addressing unmet patient needs in multiple myeloma care and making a meaningful difference in treatment outcomes at every stage of the disease across regions. If approved, this regimen would represent a new, important induction option for transplant-eligible patients, with the potential to improve long-term outcomes and deepen responses at a critical juncture in treatment.'
If approved, it would represent the fourth indication in the EU and second in the front-line setting globally. In the EU, Sarclisa is currently approved in three indications, across different lines of therapy in adult patients with relapsed and/or refractory (R/R) MM and with NDMM who are not eligible for transplant.
The GMMG-initiated study is being conducted in close collaboration with Sanofi based on jointly defined research. Sanofi provided financial support to GMMG for this study. In December 2021, Sanofi and GMMG shared results from part one, which met the primary endpoint of MRD negativity after induction therapy and before transplant in NDMM patients.
Sarclisa (isatuximab) is approved in more than 50 countries, including in the US, EU, Japan, and China, across multiple treatment lines for MM.
Based on the ICARIA-MM phase 3 study, Sarclisa is approved in the US, EU and Japan in combination with pomalidomide and dexamethasone for the treatment of patients with R/R MM who have received two prior therapies.
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