EC indication extension for J&J’s Darzalex

7 April 2025

The European Commission (EC) has approved an indication extension of Darzalex (daratumumab) subcutaneous (SC) formulation in the frontline setting.

The approval is for daratumumab SC in combination with bortezomib, lenalidomide, and dexamethasone (daratumumab-VRd) for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM), US healthcare giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen-Cilag International announced today.

Darzalex, which is licensed from Denmark’s Genmab (Nasdaq: GMAB), is already J&J’s best-selling drug, generating full-year 2024 revenues of $11.67 billion, up 20%, but now facing generic competition.

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