ORTHO BIOTECH SEEKS APPROVAL FOR DOXIL/VELCADE COMBINATION

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

The supplemental new drug application 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 Doxil plus Velcade combination or Velcade alone.

The analysis demonstrated that patients who received a combination of Doxil plus Velcade had 45 percent less risk of their disease progressing and a statistically significant improvement in median time to progression.

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