(RTTNews) - Janssen-Cilag International NV, a Johnson & Johnson company, announced the CHMP of the European Medicines Agency has recommended the approval of a Type II variation for DARZALEX, or daratumumab, subcutaneous formulation. The CHMP recommendation for daratumumab is supported by data from the Phase 3 PERSEUS study. Daratumumab is currently approved in eight indications for multiple myeloma.
The company said the positive CHMP opinion follows the recent FDA approval of daratumumab SC in combination with D-VRd for induction and consolidation in patients with newly diagnosed multiple myeloma who are eligible for autologous stem-cell transplant.
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