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FDA Accepts Application for Doxorubicin/Bortezomib Combination

BRIDGEWATER, N.J., Jan. 22 /PRNewswire/ -- Ortho Biotech Products, L.P., today announced that the U.S. Food and Drug Administration (FDA) has accepted an application for DOXIL(R) (doxorubicin HCl liposome injection) as combination therapy with VELCADE(R) (bortezomib) for injection to treat patients with multiple myeloma who have received at least one prior therapy.

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.

About DOXIL
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

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