Navigation Links
Millennium Submits sNDA for VELCADE(R) (Bortezomib) for Injection for the Treatment of Front-Line Multiple Myeloma

CAMBRIDGE, Mass., Dec. 21 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM) today announced the submission of a supplemental new drug application (sNDA) with the U.S. Food and Drug Administration (FDA) for VELCADE in the treatment of patients with previously untreated multiple myeloma (MM). The filing is based on data from the 682 patient Phase III VISTA(1) trial, one of the largest, international, randomized clinical trials for patients in this treatment setting. Janssen- Cilag International NV also submitted a Marketing Authorization Application to the European Medicines Evaluations Agency.

(Logo: )

The VISTA trial compared VELCADE, melphalan and prednisone (VcMP) to the standard regimen of melphalan and prednisone (MP) alone. For the VcMP treatment, there was a statistically significant improvement in all efficacy endpoints, including complete remission (CR) rates, time-to-disease progression (TTP) and survival.

"This submission is an important step in expanding the benefits of VELCADE therapy from patients with relapsed disease to those with previously untreated multiple myeloma. We will request a priority review and, if granted, we could expect approval by mid-2008," said Deborah Dunsire, M.D., President and Chief Executive Officer, Millennium.

(1) VELCADE as Initial Standard Therapy in multiple myeloma: Assessment

with melphalan and prednisone

About Multiple Myeloma

Multiple myeloma is the second most common hematologic 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 MM and approximately 20,000 new cases are diagnosed each year. Worldwide there are approximately 74,000 new cases and over 45,000 deaths annually.


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).

About Millennium

Millennium Pharmaceuticals, Inc., a leading biopharmaceutical company based in Cambridge, Mass., markets VELCADE, a novel cancer product, and has a robust clinical development pipeline of product candidates. Millennium's research, development and commercialization activities are focused in two therapeutic areas: oncology and inflammation. By applying its knowledge of the human genome, understanding of disease mechanisms and industrialized drug discovery platform, Millennium is developing an exciting pipeline of innovative product candidates. Millennium's website is

This press release contains "forward-looking statements," including statements about the Company's growth and development of products. Various important risks may cause the Company's actual results to differ materially from the results indicated by these forward-looking statements, including: adverse results in its drug discovery and clinical development programs; failure to obtain patent protection for its discoveries; commercial limitations imposed by patents owned or controlled by third parties; the Company's dependence upon strategic alliance partners to develop and commercialize products and services based on its work; difficulties or delays in obtaining regulatory approvals to market products and services resulting from its development efforts; product withdrawals; competitive factors; difficulties or delays in manufacturing the Company's products; government and third-party reimbursement rates; the commercial success of VELCADE and INTEGRILIN(R) (eptifibatide) Injection; achieving revenue consistent with internal forecasts; and the requirement for substantial funding to conduct research and development and to expand commercialization activities. For a further list and description of the risks and uncertainties the Company faces, see the reports it has filed with the Securities and Exchange Commission. The Company disclaims any intention or obligation to update or revise any forward- looking statements, whether as a result of new information, future events or otherwise.

Editors' Note: This press release is also available under the Media section of the Company's website at:


Jennifer Snyder (media) Kyle Kuvalanka (investors)

(617) 448-0281 (857) 498-0818

SOURCE Millennium Pharmaceuticals, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. Bear Stearns 20th Annual Healthcare Conference to Webcast Millennium Presentation
2. Synova Healthcare to Participate in Womens Health Care in the New Millennium Conference, as Retail Distribution for the Fem-V(R) Test Kit Expands
3. Statement by Bonnie J. Campbell, Former Attorney General of Iowa and Spokesperson for Atlantic Richfield Co., Millennium Holdings, LLC, NL Industries, Inc., and The Sherwin-Williams Company on the Jury Verdict Reached Today in the Thomas (Milwaukee) Case
4. 2007 Credit Suisse Healthcare Conference to Webcast Millennium Presentation
5. Millennium Announces MLN1202 Significantly Reduced Marker of Systemic Inflammation and Identifies Genomic Biomarker For Responders
6. Millennium Biotechnologies Inc. Signs Five Year $20,000,000 Purchase Agreement with Provider Services Inc. of Cleveland, Ohio
7. Millennium Pharmaceuticals Announces Webcast of American Society of Hematology Investor Event
8. Cephalon Submits New Drug Application for TREANDA for the Treatment of Chronic Lymphocytic Leukemia
9. Global Med Technologies(R), Inc. Submits ElDorado Donor(TM) to FDA
10. Johnson & Johnson Pharmaceutical Research & Development Submits New Drug Application for Paliperidone Palmitate
11. SGX Pharmaceuticals Submits Investigational New Drug Application for SGX523, a Highly Potent, Selective, Orally Bioavailable cMET Inhibitor
Post Your Comments:
(Date:11/27/2015)... (PRWEB) , ... November 27, 2015 , ... A team ... ways to treat it. Surviving Mesothelioma has just posted the findings on the ... University Hospital Zurich analyzed the cases of 136 mesothelioma patients who were treated with ...
(Date:11/27/2015)... ... November 27, 2015 , ... ProSidebar: Fashion ... Cut Pro X. With ProSidebar: Fasion, video editors can easily add an informative ... a minimalist title opener. Utilize presets featuring self-animating drop zones, lines, bars, and ...
(Date:11/27/2015)... ... November 27, 2015 , ... The moment you ... for not only fulfilling the needs of advisers and clients but going above ... and providing top-tier customer service. However, there's always room for improvement, which is ...
(Date:11/27/2015)... San Francisco, California (PRWEB) , ... November 27, 2015 , ... ... 1969 Janis Joplin Ann Arbor Michigan boxing style concert posters. This is one of ... 1969 at the Canterbury House at the University of Michigan in Ann Arbor. The ...
(Date:11/26/2015)... ... November 26, 2015 , ... ... Representative. As a franchise owner, Somu now offers travelers, value and care based ... packages, private cruise sales, as well as, cabin upgrades and special amenities such ...
Breaking Medicine News(10 mins):
(Date:11/27/2015)... Research and Markets ( ) has ... Market 2015-2019" report to their offering. ... report, the author the present scenario and growth prospects ... calculate the market size, the report considers revenue generated ... IUDs and copper IUDs. The report forecasts the global ...
(Date:11/26/2015)... Países Bajos, November 26, 2015 ... fotodinámica de Bremachlorin para el cáncer avanzado.   ... con la terapia fotodinámica de Bremachlorin para el cáncer ... enfoque combina la inmunoterapia con la terapia fotodinámica de ... Clinical Cancer Research . --> Clinical Cancer ...
(Date:11/26/2015)... Nederland, November 26, 2015 ... Een nieuwe aanpak combineert immunotherapie met Bremachlorin-photodynamische ... ) --> ...      (Photo: ) ... Universitair Medisch Centrum (LUMC) blijkt ...
Breaking Medicine Technology: