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5/14/2003

Proteasome Inhibitor Approved to Treat Multiple Myeloma

Cheryl A. Thompson

Bortezomib, a compound that inhibits the activity of a large protein complex essential to cells' ability to maintain internal equilibrium, was approved for marketing yesterday by the Food and Drug Administration.

The proteasome inhibitor is to be used for the treatment of multiple myeloma in patients who have received at least two other therapies and whose cancer worsened after the most recent treatment. Millennium Pharmaceuticals Inc. will sell bortezomib under the brand name Velcade (PDF).

According to the product's labeling, the recommended dosage is 1.3 mg/m2 administered by intravenous injection twice weekly for the first two weeks of a three-week cycle. A dose should be given on days 1, 4, 8, and 11, and then the patient should have a 10-day treatment-free period; doses should be spaced at least 72 hours apart. Therapy should be withheld if a serious toxicity develops; once the event resolves, therapy may be resumed at 75 percent of the previous dose. In the major clinical study described in the labeling, no patient received more than eight cycles of bortezomib treatment.

Use of bortezomib is contraindicated in patients with a hypersensitivity to the drug, boron (the drug is a boronic acid), or mannitol, an ingredient in the product's formulation.

During the clinical studies of bortezomib, the most commonly reported adverse events were fatigue, nausea, diarrhea, decreased appetite, constipation, low platelet count, peripheral neuropathy, fever, vomiting, and anemia—each of these developed in at least 32 percent of the patients.

Velcade will be available in single-dose vials containing 3.5 mg of bortezomib as a lyophilized powder requiring reconstitution with 3.5 mL of 0.9 percent sodium chloride injection. The package insert provided by the company on May 13 did not state the conditions under which the drug solution should be kept before administration.

A Millennium spokeswoman said the company hopes to start shipping the product by the end of May.

Update 20 May 2003—Millennium announced today that it had started shipping Velcade to wholesalers and medical centers.