Genmab Announces European Regulatory Submission for Daratumumab in Combination with Lenalidomide and Dexamethasone in Frontline Multiple Myeloma
GENMAB A/S (GMXAY)
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Source: GlobeNewswire
Company Announcement Type II variation application submitted to the EMA for daratumumab in combination with lenalidomide and dexamethasone as treatment for newly diagnosed multiple myeloma patients who are not candidates for high dose chemotherapy and autologous stem cell transplant Submission based on data from Phase III MAIA study Copenhagen, Denmark; March 22, 2019 – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that Janssen Pharmaceutica NV (Janssen) has submitted a Type II variation application to the European Medicines Agency (EMA). The application seeks to broaden the existing marketing authorization for daratumumab (DARZALEX®) to include use in combination with lenalidomide and dexamethasone (Rd) as treatment for newly diagnosed multiple myeloma patients who are not candidates for high dose chemotherapy and autologous stem cell transplant (ASCT). The submission is based on data from the Phase III MAIA study of daratumumab in combination with Rd as treatment for patient
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