FDA approves Millennium cancer drug

LOS ANGELES (Reuters) – The U.S. Food and Drug Administration on Tuesday approved the novel cancer drug Velcade, made by Millennium Pharmaceuticals Inc., as a treatment for the blood cancer multiple myeloma.

‘With its new and unique mechanism of action … Velcade is different from traditional chemotherapies and represents a new treatment option for patients,’ said Dr. Kenneth Anderson, from Dana-Farber Cancer Institute in Boston, Massachusetts.The injected drug was approved for treating patients who have failed at least two other therapies. Velcade is designed to work by blocking enzymes in tumor cells that encourage them to grow and divide.’Approval was expected, but the timing is early. They are actually going to record sales for Velcade this year,’ said Matt Geller, an analyst at CIBC World Markets.Shares of Millennium, which fell 16 cents to close at $12.49 on Nasdaq, were trading 20 percent higher at $14.85 after hours on Instinet.Geller estimated 2004 sales for Velcade of $45 million, with peak sales for multiple myeloma eventually expected to reach $200 million to $250 million a year.The Cambridge, Massachusetts-based company, which uses genomics technology to develop new drugs, believes Velcade — the first in a new class of anti-cancer agents known as proteasome inhibitors — could be a potential treatment for every kind of cancer.Over 40 clinical trials of Velcade — in other blood cancers as well as solid-tumor cancers like kidney and colon — are now underway. Results from some of those studies, as well as updated myeloma results, will be presented at the American Society of Clinical Oncology’s (ASCO) annual meeting in early June.’The data’s not there yet. We will see the first trickles of data in solid tumors at ASCO,’ Geller said.Millennium declined to comment on sales, but said Velcade is an appropriate treatment for about 25 percent of the 45,000 Americans with multiple myeloma, a relatively rare cancer that causes plasma cell tumors in the bones but sometimes other areas, particularly the lungs and reproductive organs.The drug, which will be launched in about two weeks, will cost about $20,000 for an average course of therapy, said Barry Greene, general manager of oncology at Millennium.He said the company is committed to meeting its goal of finding a marketing partner for Velcade by the end of June, but is ready to sell the drug with its own U.S. sales force.’The key focus of a partnership deal is to find a multinational partner with strong access to oncology markets outside of the U.S.,’ Greene said.In a mid-stage trial, nearly one-third of patients responded to Velcade, and almost one in five experienced remission from their cancer, the company said. The median response lasted one year, and the trial did not prove a survival benefit.Side effects included low-grade nausea and diarrhea, but the drug also delays production of blood platelets, which are needed for blood to clot, and some trial patients required blood transfusions or had their treatment stopped.Velcade was approved by the FDA in less than four months under a program that speeds review of promising products for life-threatening diseases.Millennium sought FDA review of Velcade based on the Phase 2 data — a step short of the three stages of human testing the agency usually requires before it will consider a new drug.The company said the total time frame for commercializing Velcade was 4.5 years, compared with 7.9 to 9 years for a typical cancer.(Source, ASCO, 14 May 2003, Additional reporting by Tim Dobbyn)