Published in Medical Letter on the CDC and FDA, May 1st, 2005
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 pronounced survival advantage in the second-line myeloma patients.
"We are very pleased that we now have a new standard of care in second-line treatment for multiple myeloma which has a statistically significant survival advantage,"...
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