J&J: applies to EMA for multiple myeloma treatment

(CercleFinance.com) - Johnson & Johnson announces that its subsidiary Janssen-Cilag International has applied to the European Medicines Agency (EMA) for an extension of the indication for the subcutaneous formulation of Darzalex (daratumumab) in combination with bortezomib, lenalidomide and dexamethasone (D-VRd) in the treatment of adult patients newly diagnosed with multiple myeloma (NDMM).


This request is based on the results of a Phase 3 study showing a 43% reduction in the risk of progression or death with D-VRd compared to the VRd regimen alone, and improved durable responses in patients not eligible for transplantation.

J&J says that this data adds to the body of evidence in favor of subcutaneous daratumumab in newly diagnosed multiple myeloma, and 'demonstrate the potential benefit of this quadruplet regimen for newly diagnosed patients, regardless of transplant eligibility.


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