Janssen seeks EU approval for Darzalex combination

Janssen is seeking approval from the EMA for the combination of Darzalex with Celgene’s Revlimid and corticosteroid medicine dexamethasone in patients not eligible for transplant, on the back of phase 3 MAIA study data which evaluated the regimen in multiple myeloma patients ineligible for an autologous stem cell transplant. The study compared the Darzalex with Revlimid and dexamethasone combination with Revlimid and dexamethasone alone, and the former significantly reduced the risk of disease progression or death by 44% versus the latter. The FDA are currently assessing the combination under the Real-Time Oncology Review pilot programme.

José Antonio Burón Vidal, VP Medical Affairs, Europe, Middle East and Africa (EMEA), Janssen-Cilag Limited, said: “Today’s submission brings us one step closer to our goal of improving treatment outcomes for people newly diagnosed with multiple myeloma.”