BRIEF—Third Darzalex combo gets FDA approval for frontline multiple myeloma

The US Food and Drug Administration (FDA) has approved a combination of Darzalex (daratumumab) with bortezomib, thalidomide and dexamethasone (VTd) for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant (ASCT).

Darzalex is being developed by the Johnson & Johnson (NYSE: JNJ) unit Janssen Biotech, under an exclusive worldwide license to develop, manufacture and commercialize the product from the Danish biotech company Genmab (Nasdaq: GMAB).

Jan van de Winkel, chief executive of Genmab, said: “Today’s approval is an important step forward for patients with multiple myeloma. There are now three different treatment combinations that include Darzalex for patients newly diagnosed with multiple myeloma, whether they are eligible for ASCT or not.”