Published in Medical Letter on the CDC and FDA, May 1st, 2005
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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