The US regulator has approved the combination in patients with multiple myeloma who have not received Velcade previously, but have been treated with at least one prior therapy.
The safety and efficacy of Doxil in combination with Velcade in the treatment of multiple myeloma were evaluated in a study which included 646 patients who have not previously received Velcade, but had received one prior therapy. Time to disease progression was 9.3 months in the Doxil plus Velcade group, compared to 6.5 months in the group treated with Velcade alone.
Doxil is already approved to treat ovarian cancer in some patients and AIDS-related Kaposi’s sarcoma, while Millennium’s Velcade is approved to treat multiple myeloma in patients who have been treated with at least one prior therapy.