FDA Grants Priority Review to Darzalex Combo for Multiple Myeloma

The Food and Drug Administration (FDA) granted a priority review to Darzalex (daratumumab) in combination with Velcade (bortezomib), thalidomide and dexamethasone, also known as Vtd, for the front-line treatment of newly diagnosed patients with multiple myeloma who are candidates for autologous stem cell transplant, according to Genmab —the company that co-develops Darzalex with Janssen.

The supplemental Biologics License Application for the combination included data from the randomized, open-label, multicenter phase 3 CASSIOPEIA study — designed to evaluate the combination regimen in 1,085 newly diagnosed patients with previously untreated symptomatic multiple myeloma who are eligible for high dose chemotherapy and stem cell transplant.

In the first part of the study, patients were randomized to receive induction and consolidation treatment with Darzalex combined with Vtd or just Vtd alone. The primary endpoint was stringent complete response.

he findings indicated that the rate of stringent complete response among patients treated with Darzalex plus VTD was 28.9% compared with 20.3% in those treated with VTD alone.

In the second part of the study, patients that achieved a response will undergo a second randomization to either receive maintenance treatment of Darzalex for eight weeks for up to two years versus observation. The primary endpoint was progression free survival, or the time from treatment to disease progression or worsening.

The FDA’s priority review designation is for drugs that treat a serious condition and may provide a significant improvement in safety or efficacy. The agency is set to make its decision by Sept. 26, 2019.