Navigation Links
Genzyme Withdraws Bioenvision's European Filing of Evoltra(R) in Elderly AML Patients
Date:3/19/2008

Will Resubmit With New Data from Ongoing Studies

CAMBRIDGE, Mass., March 19 /PRNewswire-FirstCall/ -- Genzyme Corp. (Nasdaq: GENZ) today announced the withdrawal of the European application to extend the Evoltra(R) (clofarabine) product label to include the treatment of elderly patients with acute myeloid leukemia (AML). This application and the data on which it was based were filed by Bioenvision, Ltd. before the company was acquired by Genzyme last year.

In a letter to the European Medicines Agency (EMEA) on behalf of Bioenvision, Genzyme states that the withdrawal is based on the EMEA's Committee for Medicinal Products for Human Use (CHMP) assessment that the data from the BIOV121 study are not sufficient to support a recommendation for market approval at this time. Bioenvision is now a wholly-owned subsidiary of Genzyme.

"As we expected, the filing that Bioenvision submitted to the EMEA was not sufficient to support approval in adult AML and our subsequent conversations with the CHMP have confirmed this assessment," stated Mark J. Enyedy, president of Genzyme Oncology, a business unit of Genzyme Corp. "We have engaged in a positive dialogue with the Rapporteurs regarding the requirements for approval and will develop a new submission to include data from one or more ongoing clinical studies of clofarabine in this patient population for submission possibly as early as the fourth quarter of this year."

In the United States, Genzyme has completed enrollment for a pivotal study in previously untreated, older adult patients with AML who are unlikely to benefit from standard intensive induction chemotherapy. Data from this study, known as CLASSIC II, are expected to provide substantial evidence for expa
'/>"/>

SOURCE Genzyme Corp.
Copyright©2008 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3

Related biology technology :

1. Novel Angiogenic Drugs, Including a Future Blockbuster from Genzyme, Could Revolutionize Treatment of Peripheral Arterial Disease
2. Genzyme Begins Major Expansion of Boston Manufacturing Facility
3. Genzyme Affirms Purchase Price for Bioenvision at $5.60 Per Outstanding Share
4. Genzyme Receives Approval to Market Elaprase(R) in Japan
5. Genzyme Recognized by Scientists as a Top Employer
6. Genzyme to Participate in FDA Advisory Committee Meeting on the Use of Phosphate Binders in Chronic Kidney Disease
7. FDA Approves Genzymes Renvela(TM) for Dialysis Patients
8. Genzyme Launches Cholestagel(R) in Europe
9. BioVex Appoints Genzyme Executive, Jan van Heek, as Chairman of the Board of Directors
10. Genzyme and Sunway to Collaborate on Gene Therapy Program in China
11. Genzyme Study of Myozyme(R) for Late-Onset Pompe Patients Meets Co-Primary Efficacy Endpoints
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/7/2008)...ected to aid drug discovery by allowing for the ra...gle reaction, ST. LOUIS, Oct. 7 /PRNewswire-First...o announce that it has signed an exclusive licensi...bana-Champaign allowing,Sigma-Aldrich to offer res...ogates for use in Suzuki-Miyaura coupling to resea...
(Date:10/7/2008)...s to focus on new patient data supporting the Ross...ynerGraft processed human heart .../- CryoLife, Inc. (NYSE: C...ocessing company, announced today,that cardiovascu...e in the,Ross Summit 2008, a two-day surgical cong...
(Date:10/7/2008)...Institutes of Health, The Infectious Disease Resea...Launch and Board of Advisors, SEATTLE, Oct. 7 /PR...,Initiative today announced its first acquisition ...osis (TB) drug candidates. Agreements were reached...nd the Microbial Chemistry,Research Foundation (MC...
(Date:10/7/2008)... Oct. 7 /- BioEnergy International, L...r and manufacturer of,next-generation, renewable b...f Norman R. Augustine to its Board of Advisors eff...f distinguished leadership and innovation,at the h...g in his role as,Chairman and Chief Executive Offi...
Breaking Biology Technology:Sigma-Aldrich and the University of Illinois Offer New Boronic Acid Surrogates to Researchers Worldwide Through Licensing Agreement 2Sigma-Aldrich and the University of Illinois Offer New Boronic Acid Surrogates to Researchers Worldwide Through Licensing Agreement 3CryoLife Hosts Worldwide Surgical Congress for the Ross Procedure 2CryoLife Hosts Worldwide Surgical Congress for the Ross Procedure 3CryoLife Hosts Worldwide Surgical Congress for the Ross Procedure 4Update: The Lilly TB Drug Discovery Initiative Begins Work on New Compounds to Fill Early-Stage TB Drug Pipeline 2Update: The Lilly TB Drug Discovery Initiative Begins Work on New Compounds to Fill Early-Stage TB Drug Pipeline 3Update: The Lilly TB Drug Discovery Initiative Begins Work on New Compounds to Fill Early-Stage TB Drug Pipeline 4Update: The Lilly TB Drug Discovery Initiative Begins Work on New Compounds to Fill Early-Stage TB Drug Pipeline 5BioEnergy International, LLC Announces Norman R. Augustine to Join Advisory Board 2BioEnergy International, LLC Announces Norman R. Augustine to Join Advisory Board 3
...icane Increases Attention of Weather Forecasting ...bel to hit the East Coast, the accuracy of weather...their homes and businesses. People are watching TV... find out the latest path of the storm. A new prod...provider of weather forecasting technology and Int...
...d you like some fries with your Internet connectio...tly began installing wireless fidelity (Wi-Fi) Int...art of a six-month pilot program. These Milwaukee ...e San Francisco Bay Area, Metropolitan New York Ci...ew McDonald,s Wireless Internet service. , ,Custom...
... confused. Governor Doyles new Growth Council seem...that theyre out of touch. After looking at the ros... three women were mentioned, to say nothing of min...t-finding mission and found that: , ,1) Four out o...omen, Gen Xers (b. 1961-1981), and minorities (Sou...
...ON, WI - Even as the State Assembly Ways and Means...-- a measure that would end state and local sales ... Representatives was passing a measure that, if it.... , ,The U.S. House Tuesday passed H.R. 49 , whic...on taxation of Internet connectivity. The bill wou...
Other Biology Technology:Hurricane Ups Weather Forecasting Attention For Madison Firm 2Wisconsin McDonalds Go Wireless 2State and Feds Race to Stop Taxation of Internet Access 2State and Feds Race to Stop Taxation of Internet Access 3State and Feds Race to Stop Taxation of Internet Access 4
(Date:10/7/2008)...imensional. That,s true even in the laboratory, wh...y develop and what happens when their growth is ab...g to develop three-dimensional cell culture system... drugs in a system that more closely mimics the wa...nt is the cost of commercial media for growing suc...
(Date:10/7/2008)...f Health (NIH) today announced the first awards fo...oundation for efforts to explore how complex commu... influence health and disease. The funding, estima...support the development of innovative technologies...lysis and an examination of some of the ethical, l...
(Date:10/7/2008)...ong Li Lab has characterized a mechanism that allo...n oocytes. By tracking chromosome movement in live...es can recruit to their vicinity a protein called ... the majority of the cytoplasm a requirement for ...he other daughter cell (called a polar body) resul...
(Date:10/7/2008)... Allergy and Infectious Diseases (NIAID), part of ...new grants to develop new and better diagnostics a...ar attack. Several of these grants were awarded un...enables NIAID within the Department of Health and ...to help stimulate research on medical countermeasu...
Breaking Biology News(10 mins):Egg whites solve the 3-D problem 2Human Microbiome Project awards funds for technology development, data analysis and ethical research 2Human Microbiome Project awards funds for technology development, data analysis and ethical research 3Human Microbiome Project awards funds for technology development, data analysis and ethical research 4NIAID announces 25 new awards to develop radiation countermeasures 2NIAID announces 25 new awards to develop radiation countermeasures 3Blue Cross and Blue Shield of Oklahoma Launches an Integrated Medical Dental Health Program 16385 1Blue Cross and Blue Shield of Oklahoma Launches an Integrated Medical Dental Health Program 16385 2Blue Cross and Blue Shield of Oklahoma Launches an Integrated Medical Dental Health Program 16385 3Indivumed Appoints Annette Kassen as Vice President Clinical Research 4500 1Indivumed Appoints Annette Kassen as Vice President Clinical Research 4500 2Module map links embryonic stem cells and cancer stem cells 16381 1Module map links embryonic stem cells and cancer stem cells 16381 2Researchers close in on origins of main ingredient of Alzheimers plaques 2831 1Researchers close in on origins of main ingredient of Alzheimers plaques 2831 2Researchers close in on origins of main ingredient of Alzheimers plaques 2831 3
...ia School of Medicine describe the basis for devel...ient,s nervous system to a thought-driven artifici... together years of spinal-cord injury research - i... , "We,re at a junction now of developing a new a...r author Douglas H. Smith, MD, Professor of Neuros...
...he National Museum of Natural History in Washingto...olve the mysterious identity of what they regard a... Their chemical analysis indicates that the organi...issue of the journal of Geology, published by the ... (pronounced pro-toe-tax-eye-tees), the organism w...
...translationally controlled tumor protein) are redu...than normal, indicating that the protein plays a m..., said researchers at Baylor College of Medicine i... , Work in his laboratory shows that TCTP plays a...n brain), a protein controlling growth and differe...
..., a bee. It all depends on what their job is. , R...uccess in adapting to cooler climates is their abi...hen flying to flowers. Whether and how they maint... now scientists from the University of Washington ... bumblebee colonies and have discovered some answe...
Other Biology News:Conceptualizing a cyborg 2Prehistoric mystery organism verified as giant fungus 2Prehistoric mystery organism verified as giant fungus 3Prehistoric mystery organism verified as giant fungus 4Bumblebee house warming -- it takes a village 2Bumblebee house warming -- it takes a village 3
MagSi uniform silica particles coated with a carboxyl group containing polymer, covalently attached to the bead surface.
Antibeta-lactoglobulin monoclonal antibody(CD-2)
MAb to Vasopressin Preservative: NaN3
...α, clone 8G8/5 GenBank Accession Number : N...lpha/gamma fusion protein corresponding to residue...0 of human AP-2γ Formulation: 0.1M Tris-glyc... the addition of glycerol to 30% Quality Assurance...
Biology Products: