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Europe: Velcade as a second-line treatment of multiple myeloma

The European Commission has approved the use of Bortezomib ( Velcade ) for Injection as a second-line treatment in patients with multiple myeloma.

Bortezomib is indicated as monotherapy for use in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplantation.

Multiple myeloma is the second most common blood cancer, representing approximately one per cent of all cancers and two per cent of all cancer deaths.
In 2002 there were approximately 85,700 cases of multiple myeloma worldwide, with over 26,000 of these cases occurring in the EU.
Only 30 per cent of multiple myeloma patients survive longer than five years.
More than 18,000 people in the EU die each year from the disease.

Velcade is a proteasome inhibitor.
Proteasomes are enzymes found in cells, and play a role in regulating cell function and growth.
Velcade blocks the activity of proteasomes.
This blockade can lead to death of cancer cells.

First approved in Europe in 2004 for the treatment of multiple myeloma patients who had received at least two prior therapies.

The second line approval is based on the results of the APEX ( Assessment of Proteasome Inhibition on Extending ) trial, an phase III study comparing Bortezomib against standard therapy high-dose Dexamethasone in patients with relapsed multiple myeloma.

The study demonstrated a significant survival advantage with Bortezomib in patients who had received one to three prior therapies.

This pronounced survival advantage also was observed in the second-line multiple myeloma patients where 55 per cent fewer patients died in the Bortezomib arm relative to Dexamethasone.

The most common side effects reported with Velcade include reversible new or worsening neuropathy; orthostatic hypotension; congestive heart failure; and gastrointestinal adverse events.

Source: Ortho Biotech, 2005