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FDA Grants Priority Review For Bortezomib for Injection in Patients With Newly Diagnosed Multiple Myeloma

CAMBRIDGE, Mass., Jan. 30 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM) today announced the U.S. Food and Drug Administration (FDA) granted priority review for Velcade in patients with newly diagnosed multiple myeloma (MM). The supplemental New Drug Application (sNDA) submitted to the FDA for this indication included data from the Phase III VISTA(1) study, a large, well-controlled international clinical trial, comparing a Velcade based regimen to a traditional standard of care. Velcade is the market-leader for MM and mantle cell lymphoma patients who have received at least one prior therapy.

"Priority review designation puts us on track for a potential label expansion decision by June 20," said Nancy Simonian, M.D., Chief Medical Officer, Millennium. "The rapid action by the FDA puts us one step closer to establishing Velcade based therapies as a standard of care for patients with newly diagnosed multiple myeloma."

Priority review is granted by the FDA for a treatment that addresses an unmet medical need and demonstrates an improvement over existing therapies. The FDA expedites the approval process for applications granted priority review from ten to six months.

The VISTA trial randomized 682 patients with newly diagnosed MM ineligible for stem cell transplantation and was conducted by the Company and its co- development partner Johnson & Johnson Pharmaceutical Research & Development, L.L.C. The trial compared Velcade, melphalan and prednisone (VcMP) to the standard regimen of melphalan and prednisone (MP) alone. VcMP achieved a statistically significant improvement across all efficacy endpoints, including complete remission (CR) rates, time-to-disease progression (TTP) and survival (progression-free survival and overall survival). Included in these results, VcMP demonstrated an immunofixation-negative CR rate of 35 percent, which is the highest rate reported in a Phase III trial in patients with newly diagnosed MM, compared to 5 percent in the MP arm.

About Multiple Myeloma
Multiple myeloma is the second most common hematological malignancy and although the disease is predominantly a cancer of the elderly (the median age of onset is 70 years of age), recent statistics indicate both increasing incidence and younger age of onset. In the U.S., more than 55,000 individuals have multiple myeloma and approximately 20,000 new cases are diagnosed each year. Worldwide there are approximately 74,000 new cases and over 45,000 deaths annually.

About Velcade
Velcade is being co-developed by Millennium Pharmaceuticals, Inc. and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Millennium is responsible for commercialization of Velcade in the U.S., Janssen-Cilag is responsible for commercialization in Europe and the rest of the world. Janssen Pharmaceutical K.K. is responsible for commercialization in Japan. For a limited period of time, Millennium and Ortho Biotech Inc. currently co-promote Velcade in the U.S. Velcade is approved in 85 countries worldwide. More than 85,000 patients have been treated with Velcade globally.

In the U.S., Velcade is indicated for the treatment of patients with multiple myeloma who have received at least one prior therapy. Velcade is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. Velcade is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol. Velcade should be administered under the supervision of a physician experienced in the use of antineoplastic therapy. In the European Union and many other countries worldwide, Velcade is approved for patients with multiple myeloma after first relapse.

Risks associated with Velcade therapy include new or worsening peripheral neuropathy, hypotension observed throughout therapy, cardiac and pulmonary disorders, gastrointestinal adverse events, thrombocytopenia, neutropenia and tumor lysis syndrome. Women of childbearing potential should avoid becoming pregnant while being treated with Velcade. Cases of severe sensory and motor peripheral neuropathy have been reported. The long-term outcome of peripheral neuropathy has not been studied in mantle cell lymphoma. Acute development or exacerbation of congestive heart failure, and/or new onset of decreased left ventricular ejection fraction has been reported, including reports in patients with few or no risk factors for decreased left ventricular ejection fraction. There have been rare reports of acute diffuse infiltrative pulmonary disease of unknown etiology such as pneumonitis, interstitial pneumonia, lung infiltration and Acute Respiratory Distress Syndrome in patients receiving Velcade. Some of these events have been fatal. A higher proportion of these events have been reported in Japan. There have been rare reports of Reversible Posterior Leukoencephalopathy Syndrome (RPLS) in patients receiving Velcade. RPLS is a rare, reversible, neurological disorder which can present with seizure, hypertension, headache, lethargy, confusion, blindness, and other visual and neurological disturbances. Velcade is associated with thrombocytopenia and neutropenia. There have been reports of gastrointestinal and intracerebral hemorrhage in association with Velcade. Transfusions may be considered. Complete blood counts (CBC) should be frequently monitored during treatment with Velcade. Rare cases of acute liver failure have been reported in patients receiving multiple concomitant medications and with serious underlying medical conditions.

Integrated Safety Data: Safety data from phase 2 and 3 studies of single- agent Velcade 1.3 mg/m2/dose twice weekly for 2 weeks followed by a 10-day rest period in 1163 patients with multiple myeloma (N=1008) and mantle cell lymphoma (N=155) were integrated and tabulated. In these studies, the safety profile of Velcade was similar in patients with multiple myeloma and mantle cell lymphoma. In the integrated analysis, the most commonly reported adverse events were asthenic conditions (including fatigue, malaise, and weakness) (64%), nausea (55%), diarrhea (52%), constipation (41%), peripheral neuropathy NEC (including peripheral sensory neuropathy and peripheral neuropathy aggravated) (39%), thrombocytopenia and appetite decreased (including anorexia) (each 36%), pyrexia (34%), vomiting (33%), and anemia (29%). Twenty percent (20%) of patients experienced at least 1 episode of greater than or equal to Grade 4 toxicity, most commonly thrombocytopenia (5%) and neutropenia (3%). A total of 50% of patients experienced serious adverse events (SAEs) during the studies. The most commonly reported SAEs included pneumonia (7%), pyrexia (6%), diarrhea (5%), vomiting (4%), and nausea, dehydration, dyspnea and thrombocytopenia (each 3%). Adverse events thought by the investigator to be drug-related and leading to discontinuation occurred in 22% of patients. The reasons for discontinuation included peripheral neuropathy (8%), asthenic conditions (3%) and thrombocytopenia and diarrhea (each 2%). In total, 2% of the patients died and the cause of death was considered by the investigator to be possibly related to study drug: including reports of cardiac arrest, congestive heart failure, respiratory failure, renal failure, pneumonia and sepsis. This integrated analysis does not include the phase 3, Velcade plus DOXIL study.

For more information about Velcade clinical trials, patients and physicians can contact the Millennium Medical Product Information Department at 1-866-Velcade (1-866-835-2233).

Source: Millennium Pharmaceuticals

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