WEDNESDAY, May 14, 2003 (HealthDayNews) -- The U.S. Food and Drug Administration (FDA) has rushed to approve an unproven treatment for one of the most difficult-to-treat cancers -- a malignancy of the blood called multiple myeloma.
After an accelerated review process that lasted less than four months, the agency voted to approve Velcade (bortezomib), the first drug in a new class of cancer-fighting medications called proteasome inhibitors. It targets an enzyme that's responsible for the out-of-control growth of cancerous cells.
Velcade is approved for patients whose disease has relapsed after two prior treatments and who have not responded well to the last regimen. Clinical trials involving 188 participants showed 28 percent improved while taking the drug.
Accelerated approval was granted under an FDA program that lets manufacturers market their drugs for life-threatening conditions before the medications are entirely proven safe. The agency has ordered Velcade's maker, Millennium Pharmaceuticals, to conduct additional studies.
Multiple myeloma is the second most prevalent blood cancer after non-Hodgkin's lymphoma. It now affects about 45,000 people in the United States, and some 14,600 new cases are diagnosed annually.