EC Expands SC Daratumumab’s Indication for Use in All Transplant Eligibility Settings in Newly Diagnosed Myeloma

Daratumumab Combo Earns EU Approval in Newly Diagnosed Multiple Myeloma

Data from the phase 3 CEPHEUS trial support the European Commission’s approval of the daratumumab-based regimen.

Europe extends Darzalex approval as multiple myeloma treatment

The European Commission has extended its approval of Johnson & Johnson’s Darzalex (daratumumab) for injection under the skin as part of a quadruple regimen for first-line treatment of adults with newly diagnosed multiple myeloma. The quadruple regimen includes the subcutaneous (under-the-skin) formulation of Darzalex, marketed in the U.S. as Darzalex Faspro, in combination with bortezomib, lenalidomide, and dexamethasone — a standard triple ther…

EC grants indication extension approval for Darzalex

The European Commission (EC) has granted approval for the extension of indication for Janssen-Cilag International’s Darzalex SC formulation.

EC Expands SC Daratumumab’s Indication for Use in All Transplant Eligibility Settings in Newly Diagnosed Myeloma

The European Commission approved subcutaneous daratumumab plus VRd for newly diagnosed multiple myeloma, regardless of transplant eligibility.