This approval expands the label to include the treatment of multiple myeloma patients who have received at least one prior therapy, and thus doubles the number of patients who could benefit from the treatment. Velcade (bortezomib) is now fully approved in relapsed multiple myeloma, a cancer of the blood.
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,” said Dr Brian Durie, chairman of the board of the International Myeloma Foundation.
Millennium will continue, in partnership with Johnson & Johnson Pharmaceutical R&D, to evaluate Velcade in multiple myeloma as well as in other hematologic and solid tumors.