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Johnson & Johnson’s Darzalex with Halozyme’s Enhanze granted EU approval

Halozyme (HALO) announced that Janssen-Cilag International, a Johnson & Johnson (JNJ) company, received European Commission approval for an indication extension of Darzalex – daratumumab – subcutaneous co-formulated with 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. This approval follows the indication extension approval for daratumumab-VRd in October 2024, for the treatment of newly diagnosed patients with multiple myeloma who are eligible for autologous stem cell transplant.

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