Millennium Submits sNDA for VELCADE(R) (Bortezomib) for Injection for the Treatment of Front-Line Multip...(s not been studied in mantlecell lymphom...),Health

Date:12/21/2007

s 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
'/>"/>

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

0 GOOD

Page: 1 2 3 4 5
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