On January 19, the U.S. Food and Drug Administration (FDA) granted Priority Review to the supplemental Biologics License Application (sBLA) for the use of daratumumab (Darzalex) in combination with bortezomib (Velcade), melphalan, and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).
Priority Review is an FDA designation for drugs that treat a serious condition and may provide a significant improvement in safety or efficacy. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target date of May 21, 2018, to make a decision on daratumumab in this indication.
“The granting of Priority Review to the submission of daratumumab in [the] front-line multiple myeloma [setting] is an important step forward toward potentially bringing this product to an even larger number of patients in need,” said Jan van de Winkel, PhD, Chief Executive Officer of Genmab.
The sBLA submission was based on data from the phase III ALCYONE study of daratumumab in combination with bortezomib, melphalan, and prednisone in front-line multiple myeloma. These data were presented as a late-breaking abstract at the 59th American Society of Hematology (ASH) Annual Meeting & Exposition and published in The New England Journal of Medicine.
About the ALCYONE study
The phase III ALCYONE study is a randomized, open-label, multicenter study that includes 706 newly diagnosed patients with multiple myeloma who are ineligible for ASCT. Patients were randomized to receive 9 cycles of either VMP (bortezomib, melphalan, and prednisone) 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.
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