FDA Approves Millennium Pharmaceuticals, Inc. VELCADE For Injection For Aggressive Form Of Mantle Cell Lymphoma

CAMBRIDGE, Mass.-- Millennium Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted full approval of VELCADE for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. MCL is a relatively uncommon and aggressive form of non-Hodgkin's lymphoma for which there was no standard of care in the relapsed or refractory setting. MCL has a U.S. prevalence of 10,000 patients. VELCADE is currently the market leader in multiple myeloma (MM) for patients who have received one prior therapy. The approval marks the first indication for VELCADE in lymphoma, the most common blood cancer.

"Mantle cell lymphoma is the most challenging lymphoma to treat because it is commonly resistant to chemotherapy in the relapsed setting," said Andre Goy, M.D., Chief of The Division of Lymphoma, The Cancer Center at Hackensack University Medical Center in Hackensack, N.J. "This approval offers new hope for patients with mantle cell lymphoma who have received at least one prior therapy."

"VELCADE is the first drug to receive FDA approval in relapsed mantle cell lymphoma and is based upon the data from our Phase II trial. This represents a new option for patients and a significant milestone for Millennium," said Deborah Dunsire, M.D., President and CEO, Millennium. "In conjunction with our co-development partner, Johnson & Johnson Pharmaceutical Research & Development (J&JPRD), VELCADE is also being investigated in clinical studies in patients with newly diagnosed multiple myeloma and additional types of non-Hodgkin's lymphoma."

The approval is based on data from the PINNACLE trial, the largest study to date in patients with MCL. PINNACLE was a prospective, multi-center, single-arm, open-label study in patients with MCL whose disease progressed following at least one prior therapy. Response rates to VELCADE were determined according to the International Workshop Response Criteria (IWRC) and based on independent radiologic review of CT scans.

What MCL is and how the drug will treat it:
(MCL) is an aggressive type of non-Hodgkin's lymphoma that generally occurs in middle-aged and elderly people and is becoming increasingly recognized. MCL is a disease of B lymphocytes -- cells that make antibodies to help fight infection -- and is typically found in the lymph nodes, spleen, bone marrow, or blood; it is often diagnosed at an advanced stage. Although MCL usually responds to standard chemotherapy, the responses are not long lasting.

Velcade is a potent, specific, and reversible proteasome inhibitor and the first drug of this type to enter clinical trials. Proteasomes are present in all cells and function to help regulate cell growth. In nonclinical studies, normal cells appear to be able to recover from intermittent proteasome inhibition, but many types of cancer cells undergo apoptosis (programmed cell death) when proteasomes are inhibited, even for a short time.

The proteasome is an enzyme complex that exists in all cells and plays an important role in degrading proteins involved in the cell cycle, growth of new blood vessels (angiogenesis), cell adhesion, cytokine production, apoptosis, and other important cellular processes. Many of the processes that rely on proteasome function can contribute to the growth and survival of cancer cells. Velcade is a potent but reversible inhibitor of the proteasome. By disrupting normal cellular processes, proteasome inhibition promotes apoptosis. Non-clinical data has demonstrated that cancer cells are more susceptible to the effects of proteasome inhibition than normal cells. Due to the reversibility of proteasome inhibition with Velcade, normal cells can recover from its effects, whereas cancer cells are more likely to undergo apoptosis.

This is huge for any leukemia patients that are not responding to initial therapies. I will look for the long term survival rate data and post. As for the market impact, MLNM can look to, in my opinion if the drug is successful, dominate. Watching the stock in pretrading hours-there could be an opportunity here early monday.

MLNM closed friday's trading up 16 cents per share at $11.42.