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New Data on Market-Leading Velcade (Bortezomib) for Injection,Further Strengthen Role in Previously Treated Multiple Myeloma

(IV) administration option. Results were presented by Philippe Moreau, M.D., University Hospital Hotel-Dieu and showed:

    -- Similar bioavailability for the two routes of administration

    -- Similar safety and tolerability profiles for the two routes of

       administration with a trend favoring the SC route as evidenced by fewer

       patients in this group discontinuing therapy

    -- Identical response rates for the two routes of administration with both

       groups of patients achieving an overall response rate (complete and

       partial response) of 42 percent

The trial included 24 patients who were randomized to receive either SC or IV injections of VELCADE at the standard dose of 1.3 mg/m2 twice weekly for two weeks on days 1, 4, 8 and 11 with one week rest for up to eight cycles. Blood samples were taken on days 1 and 11 to measure PK by plasma Cmax (maximum plasma concentration), AUC (area under plasma concentration-time curve) and Tmax (time to Cmax) values and to measure PD by AUE (area under effect curve) and Emax (maximum effect) values. Patients received a median number of six and five cycles in the IV and SC groups, respectively.

Effect of the Combination of Pegylated Liposomal Doxorubicin and Bortezomib on Time to Progression (TTP) and Overall Survival of Patients With Relapsed/Refractory Multiple Myeloma Compared With Bortezomib Alone (Abstract #8002)

"The combination of VELCADE + DOXIL is highly active, with the time to disease progression the strongest in any U.S.-approved label for this patient population," said Jean-Luc Harousseau, M.D., University Hospital Hotel-Dieu. "Based on the Phase II trial, which showed a median overall survival greater than 38 months, we believe that the strong efficacy of the combination in the Phase III trial will extend to a substantial improvement in overall survival as well."

The Phase III study compared the efficacy and safety of the combination of VELCADE
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2. Velcade (Bortezomib) for Injection Based Therapies Produced Complete Remission Rates as High as 54 Percent in Patients With Previously Treated Multiple Myeloma
3. Velcade (bortezomib) for Injection Based Therapies Achieved Survival Rates as High as 100 Percent in Newly Diagnosed Multiple Myeloma Patients
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