FDA Grants Priority Review to Combination Regimen to Treat Multiple Myeloma

The FDA granted a priority review to daratumumab (Darzalex) in combination with bortezomib (Velcade), thalidomide and dexamethasone (Vtd) for the front-line treatment of newly diagnosed patients with multiple myeloma who are candidates for autologous stem cell transplant.

The FDA granted a priority review to daratumumab (Darzalex) in combination with bortezomib (Velcade), thalidomide and dexamethasone (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 FDA set a Prescription Drug User Fee Act (PDUFA) target date of September 26, 2019.

The supplemental Biologics License Application for the combination included data from the randomized, open-label, multicenter phase III 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 daratumumab combined with Vtd or just Vtd alone. The primary endpoint was stringent complete response (sCR).

The findings indicated that the rate of sCR among patients treated with daratumumab 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 daratumumab for eight weeks for up to two years versus observation. The primary endpoint is progression free survival.