Johnson & Johnson (NYSE: JNJ) has secured European approval for an expanded indication of Darzalex (daratumumab) in a subcutaneous formulation.
The drug, when combined with bortezomib, lenalidomide, and dexamethasone, can now be used for newly diagnosed multiple myeloma (MM) patients eligible for autologous stem cell transplant.
The decision is backed by results from the Phase III PERSEUS study, which demonstrated a 58% reduction in the risk of disease progression or death for patients receiving the Darzalex-based regimen, compared to the standard treatment.
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