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FDA Accepts Application for Doxorubicin/Bortezomib Combination
The Supplemental New Drug Application (sNDA) is based on a planned interim analysis from the DOXIL-MMY-3001 trial, an international, multicenter, phase 3, randomized, open-label study of 646 patients with relapsed or refractory multiple myeloma who had received at least one prior line of therapy, and who were randomized to receive the DOXIL + VELCADE combination or VELCADE alone. For more information about the DOXIL-MMY-3001 interim analysis, go to: http://www.orthobiotech.com/releaseDetail.jsp?releaseID=300001.
"We are pleased that the FDA has accepted our sNDA, as this promising combination would provide an expanded treatment option for patients with relapsed/refractory multiple myeloma," said Craig Tendler, M.D., Vice President, Clinical Affairs, Ortho Biotech.
DOXIL currently is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy.
Source: Ortho Biotech Products