( + DOXIL to VELCADE monotherapy the sta...)New Data on Market-Leading Velcade (Bortezomib) for Injection,Further Strengthen Role in Previously Treated Multiple Myeloma,Health

    -- A survival advantage was observed for the VELCADE + DOXIL combination,

       after approximately 20 percent of events occurred (p<0.05, hazard

       ratio=1.406, 95 percent confidence interval [1.002; 1.972])

    -- Median time to progression (TTP) of 9.3 months for the combination, a

       43 percent, highly statistically significant reduction in risk of

       disease progression over the control arm (p<0.00001)

    -- A predictable safety profile consistent with the known toxicities of

       the two agents, including thrombocytopenia, neutropenia and anemia

The trial included 646 patients who had received at least one prior therapy. Patients were randomized in a one-to-one ratio, with 322 patients receiving VELCADE at 1.3 mg/m2 on days 1, 4, 8 and 11 of the 21-day cycle and 324 patients receiving the same dose and schedule of VELCADE with the addition of DOXIL at 30 mg/m2 given on day 4 of each cycle. Patients were treated for up to eight cycles. The primary endpoint of the study was TTP as defined by the interval between the date of randomization and the date of disease progression, including relapse after complete response or death due to disease progression. In both arms, 66 percent of patients had received more than two prior therapies before entering the trial. Responses were assessed by European Group for Blood and Marrow Transplantation (EBMT) criteria.

About Multiple Myeloma (MM)

Multiple myeloma is the second most common hematologic malignancy and although the disease is predominantly a cancer of the elderly (the average age of onset is 65 to 70 years of age), recent statistics indicate both increasing incidence and younger age of onset. In the U.S., more than 50,000 individuals have MM and 20,000 new cases are diagnosed each year. Worldwide there are approxi
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