Wednesday, January 30, 2008

Millennium wins fast-track status for new Velcade use

The U.S. Food and Drug Administration has granted priority review of Millennium Pharmaceuticals Inc.'s drug Velcade to treat new cases of a form of blood cancer. The priority review puts the new use of Velcade on track for possible approval in the first half of 2008, company officials said.

Millennium, a Cambridge-based biotechnology company, said Velcade is already approved for multiple myeloma in patients who have not responded to at least one previous treatment.

The FDA grants priority review for drugs that serve unmet needs in health care and show improvement over existing treatments, the company said. Velcade has been tested as an initial treatment for multiple myeloma combined with standard chemotherapy compounds melphalan and prednisone compared with melphalan and prednisone only, and the Velcade combination showed "statistically significant improvement."

Millennium, which develops and markets Velcade with a unit of New Jersey-based health products giant Johnson & Johnson, reported a 2006 net loss of $43.95 million on revenue of $486.8 million.