The USFDA has accepted Ortho Biotech Products, L.P.(4336966)’s Supplemental New Drug Application (sNDA) for DOXIL® (doxorubicin HCl liposome injection) as combination therapy with VELCADE® (bortezomib) for injection to treat multiple myeloma patients who have received at least one prior therapy.
DOXIL® is currently indicated for the treatment of ovarian cancer patients whose disease has progressed or recurred after platinum-based chemotherapy while VELCADE® is the market leader in relapsed multiple myeloma.
According to Craig Tendler, M.D., Vice President, Clinical Affairs, Ortho Biotech:
"We are pleased that the FDA has accepted our sNDA, as this promising ombination would provide an expanded treatment option for patients with elapsed/refractory multiple myeloma.”
DOXIL is marketed in the United States by Ortho Biotech Products, L.P., and in Israel by Janssen-Cilag while Schering-Plough Corporation has exclusive rights to market the medication as CAELYX® throughout the rest of the world (excluding Japan).
Find more details from the press release.
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