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FDA Approves Bortezomib for Injection for Aggressive Form of Non-Hodgkin's Lymphoma

CAMBRIDGE, Mass., Dec. 8 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM) today 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. Today's 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. Results of the study, which formed the basis of the approval, include:

  • Overall response rate of 31 percent
  • Complete response (CR + CRu) rate of 8 percent
  • Median duration of response of 9.3 months; 15.4 months in patients achieving a complete response
  • Median time to progression of 6.2 months
  • In PINNACLE, the most commonly reported adverse events were asthenic conditions (72%), peripheral neuropathy (55%), constipation (50%), diarrhea (47%), nausea (44%), decreased appetite (39%), rash (28%), edema (28%), vomiting (27%), dizziness (23%), dyspnea (23%), insomnia (21%) and thrombocytopenia (21%).
VELCADE is now being studied by two U.S. cooperative groups. The first study, conducted by the Southwest Oncology Group (SWOG), is in the frontline setting. The second study, conducted by the Cancer and Leukemia Group B (CALGB), is evaluating the combination with R-CHOP as consolidation or maintenance following transplant. Earlier this year, Millennium and co-development partner, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), initiated an international Phase III clinical trial with VELCADE in combination with rituximab in patients with relapsed or refractory follicular lymphoma, another subtype of non-Hodgkin's lymphoma. Additionally, more than 170 clinical trials with VELCADE are ongoing in various disease settings, both company sponsored and investigator initiated.

VELCADE is also approved for the treatment of patients with MM who have received at least one prior therapy. VELCADE is the first and only single agent to provide a survival benefit in patients with relapsed multiple myeloma. To date, more than 50,000 patients, including individuals in clinical trials, have been treated with VELCADE in more than 75 countries.

About Non-Hodgkin's Lymphoma and Mantle Cell Lymphoma
Non-Hodgkin's lymphoma (NHL) is the most common hematological cancer, the fifth leading cause of cancer death and the second fastest growing form of cancer in the U.S.(1) The prevalence of NHL in the U.S. is approximately 400,000 patients, 77,000 patients with follicular lymphoma and 10,000 with mantle cell lymphoma. There are approximately 54,000 new cases of NHL diagnosed in the U.S. per year, and 19,000 deaths are attributed to the disease annually(1-4).

Mantle cell lymphoma is an aggressive, rapidly progressive subtype of NHL, and is not curable with standard treatment. The median life expectancy for a patient with MCL following first relapse is 1-2 years.

Source: Millennium Pharmaceuticals

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