Halozyme Therapeutics (HALO) announced that Janssen-Cilag International NV, a Johnson & Johnson company, received European Commission approval for an indication extension of DARZALEX, or daratumumab, subcutaneous co-formulated with Halozyme's ENHANZE in the frontline setting. The approval is for daratumumab SC in combination with bortezomib, lenalidomide, and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma.
Helen Torley, CEO of Halozyme, said: "This approval means that newly diagnosed patients can receive daratumumab subcutaneous plus VRd and avoid the need for lengthy IV infusions."
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