The FDA has granted Priority Review to the supplemental Biologics License Application (sBLA) for the use of daratumumab in combination with bortezomib, melphalan, and prednisone (VMP) for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).
The sBLA submission was based on data from the phase III ALCYONE study (NCT02195479) of daratumumab in combination with bortezomib, melphalan, and prednisone in front-line multiple myeloma (N Engl J Med 2017; doi:10.1056/NEJMoa1714678).
This randomized, open-label, multicenter study includes 706 newly diagnosed patients with multiple myeloma who are ineligible for ASCT. Patients were randomized to receive nine cycles of either VMP combined with daratumumab, or VMP alone.
In the daratumumab treatment arm, patients received 16 mg/kg of daratumumab once weekly for 6 weeks (cycle 1; 1 cycle=42 days), followed by once every 3 weeks (cycles 2-9). Following the 9 cycles, patients in the daratumumab treatment arm continued to receive 16 mg/kg of daratumumab once every 4 weeks until disease progression. The primary endpoint of the study is progression-free survival.