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Myeloma Minute Special Edition: Important VELCADE® News


03.25.05

FDA Approves VELCADE® for Use in Second-Line Multiple Myeloma

This approval expands the label to include the treatment of multiple myeloma patients who have received at least one prior therapy. The approval was based on data from the randomized Phase III APEX study that compared single-agent VELCADE to high-dose dexamethasone. The study demonstrated a statistically significant survival advantage in the VELCADE arm of the study.

  • The study showed that with VELCADE, we now have a new standard of care in second line treatment for multiple myeloma.

  • There was a statistically significant survival advantage with the use of VELCADE in this setting. There was a 75% higher risk of death with dexamethasone as compared to VELCADE in the overall patient population.

  • The study demonstrated that earlier use of VELCADE resulted in a higher overall response of 45% (complete response + partial response) in second line patients.

  • In the overall study, 13% of patients had a complete response or near complete response with VELCADE, which was associated with a longer duration of response.

Initial accelerated approval for VELCADE used in relapsed and refractory myeloma was granted in May 2003. VELCADE is now fully approved in relapsed myeloma.

Read Millennium's Press Release.

Listen to Dr. Paul Richardson discuss his presentation of the final results of the APEX trial at ASH 2004.

More about VELCADE...


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