Ortho Biotech announced the US Food and Drug Administration (FDA) has approved the use of liposomal doxorubicin (Doxil) in combination with bortezomib (Velcade) to treat patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy.
The approval is based on the results of an international phase III trial comparing the combination to bortezomib alone. The research showed that when used together to treat patients with relapsed/refractory multiple myeloma, the two medications significantly extended the median time to disease progression from 6.5 months to 9.3 months (P < .0001; hazard ratio = 0.55; 95% confidence interval = 0.43-0.71) over bortezomib alone.
Important New Option
"The Velcade-plus-Doxil combination represents an important new therapeutic option for multiple myeloma, a disease that is incurable and has limited treatments available," said Kathy Giusti, chief executive officer and founder of the Multiple Myeloma Research Foundation, and a myeloma patient. "The FDA approval of this promising combination signifies a critical milestone in the quest to treat patients with multiple myeloma."
The FDA approved Ortho Biotech's Supplemental New Drug Application (sNDA) for the combination under the agency's Priority Review program. The approval was based on a preplanned, interim analysis from the DOXIL-MMY-3001 study, an international, multicenter, phase III, randomized, open-label study of 646 patients with relapsed or refractory multiple myeloma who had not previously received bortezomib. For more information about the DOXIL-MMY-3001 study results, go to http://www.orthobiotech.com/releaseDetail.jsp?releaseID=300001.