22 March 2019 - 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.
Genmab announced today that Janssen has submitted a Type II variation application to the 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 patients with newly diagnosed multiple myeloma, who are not candidates for high dose chemotherapy and ASCT.