European Commission approves Genmab’s Darzalex combo in newly diagnosed multiple myeloma
Genmab’s Darzalex (daratumumab) has secured approval from the European Commission and is now authorised in Europe for the treatment of newly diagnosed multiple myeloma when used in combination with lenalidomide and dexamethasone, it has emerged.
The approval covers adult patients with condition who are ineligible for autologous stem cell transplant (ASCT), and delivers on the recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on October, just a month prior.
Phase 3 data demonstrating the efficacy of this Darzalex combo in newly diagnosed multiple myeloma patients who are not eligible for high dose chemotherapy and ASCT was used in support of the deciusion.
Dr Jan van de Winkel, Chief Executive Officer of Genmab, commented on the ruling: “We are pleased that with this approval, patients in the European Union newly diagnosed with multiple myeloma who are not candidates for transplant will now have two potential options for treatment with Darzalex containing regimens. We look forward to seeing the combination therapy of Darzalex with lenalidomide and dexamethasone launched in Europe.”
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