sNDA Accepted for Liposomal Doxorubicin/Bortezomib in Relapsed/Refractory Multiple Myeloma

February 1, 2007
Oncology, ONCOLOGY Vol 21 No 2, Volume 21, Issue 2

Ortho Biotech recently announced that the US Food and Drug Administration (FDA) has accepted an application for doxorubicin HCl liposome injection (Doxil) as combination therapy with bortezomib (Velcade) to treat patients with multiple myeloma who have received at least one prior therapy.

Ortho Biotech recently announced that the US Food and Drug Administration (FDA) has accepted an application for doxorubicin HCl liposome injection (Doxil) as combination therapy with bortezomib (Velcade) to treat patients with multiple myeloma who have received at least one prior therapy.

Phase III Trial

The Supplemental New Drug Application (sNDA) is based on a planned interim analysis from the DOXIL-MMY-3001 trial, an international, multicenter, phase III, 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 liposomal doxorubicin-plus-bortezomib combination or bortezomib 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, MD, vice president, clinical affairs, Ortho Biotech.

Liposomal doxorubicin currently is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy.