Millennium Pharmaceuticals Inc. has been granted Velcade fast track designation by US FDA for relapsed and refractory mantle cell lymphoma, an aggressive form of non-Hodgkin's lymphoma (NHL) which accounts for approximately six percent of all lymphomas.

Currently, Velcade is being evaluated as a single agent in a Company-sponsored multi-centre phase II clinical trial for the treatment of mantle cell lymphoma in addition to multiple investigator-initiated trials. These trials are part of an ongoing research collaboration between Millennium and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. to jointly investigate Velcade in haematologic and solid tumours. Velcade is currently indicated for the treatment of multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy, the company release said.

"We are pleased that the FDA has recognized the unmet medical need of patients suffering from mantle cell lymphoma," David Schenkein, vice president, clinical oncology development, Millennium said adding, "Mantle cell lymphoma remains one of the deadliest forms of cancer and is generally considered incurable. Millennium remains committed to the clinical development and registration of Velcade as a treatment for the critical unmet medical needs of patients suffering from mantle cell lymphoma."

The fast track designation is based on preliminary data from an ongoing Company-sponsored phase II clinical trial of Velcade in patients with relapsed or refractory mantle cell lymphoma, and the commitment to a full development program designed to lead to registration. The trial, initiated in June 2003, is designed to assess time to progression, response rate, duration of response and overall survival in patients with relapsed or refractory mantle cell lymphoma following one or two prior chemotherapeutic regimens. Millennium anticipates interim data will be presented at the American Society of Clinical Oncology (ASCO) annual meeting in 2005.

Support of this designation was based on data from four separate phase II investigator-initiated studies of Velcade as a single agent for the treatment of indolent and aggressive NHL which were presented at the 2003 and 2004 American Society of Clinical Oncology (ASCO) meetings and the 2003 American Society of Haematology (ASH) meeting. Additionally, Millennium anticipates further data from two of these studies will be submitted for presentation at the December American Society of Haematology 46th annual meeting in San Diego, California, the release added.

Velcade is currently approved in the United States, 27 European Union states, South Korea, Argentina and Israel. Velcade is being co-developed by Millennium and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Millennium is responsible for commercialization of Velcade in the US; Ortho Biotech and Janssen-Cilag are responsible for commercialization in Europe and the rest of the world. Janssen Pharmaceutical K.K. will be responsible for Japan.