FDA approves Genmab's Darzalex combo in newly diagnosed multiple myeloma

Genmab’s CD38 inhibitor Darzalex (daratumumab) has been awarded marketing authorisation from the FDA in combination with bortezomib, thalidomide and dexamethasone (VTd) in the treatment of newly diagnosed multiple myeloma (MM) in patients who are eligible for autologous stem cell transplant (ASCT), it has emerged.

The decision was made via the US regulator’s Priority Review pathway and based on Phase 3 data supporting the efficacy of the Darzalex combo in 1,085 newly diagnosed, previously untreated symptomatic MM patients eligible for ASCT

Janssen was granted exclusive worldwide rights for the product from Genmab in 2012 to develop, manufacture and market the drug.

“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,” said Dr Jan van de Winkel, Chief Executive Officer of Genmab. “We are grateful for the efforts of the IMF, HOVON and Janssen that led to the strong data from the CASSIOPEIA trial, which formed the basis of this new approval.”

Matt Fellows