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news.Janssen-Cilag International has submitted a Type II variation application to the European Medicines Agency (EMA), for its immunotherapy Darzalex (daratumumab).
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The application seeks to broaden the existing marketing authorisation to include daratumumab in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
“This submission to health authorities takes us one step closer to our goal of redefining combination therapy in multiple myeloma, with the potential to make daratumumab available to more patients throughout the treatment continuum: from newly diagnosed, to heavily pre-treated,” said Dr Catherine Taylor, Haematology Therapeutic Area Lead, Janssen Europe, Middle East and Africa (EMEA).
“We look forward to working closely with the EMA throughout the review process to deliver on this ambition to optimise clinical benefits for multiple myeloma patients.”
The regulatory submission is now pending validation by the EMA and is supported by data from the Phase 3 ALCYONE (MMY3007) study.
Daratumumab is currently indicated for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent, and who have demonstrated disease progression on the last therapy.