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

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:9/2/2015)... ... September 02, 2015 , ... The TS5-Q ... professional commercial video content, to analysis of athletic performance. Producing high-resolution slow-motion ... by too quickly to process with the naked eye. , Slow motion ...
(Date:9/1/2015)... ... September 02, 2015 , ... Spirax Sarco , the leader in products ... Spirax Sarco Anytime. This platform, offering unique online ordering capabilities, is only available ... Log on to Spirax Sarco Anytime and within minutes you can be making ...
(Date:9/1/2015)... , Sept. 1, 2015 Prostate ... death in American men. One in seven ... 233,000 new cases are diagnosed annually. That said, ... using a powerful new technique, MRI Fusion Biopsy, ... large cancer lesions, treating only the affected areas ...
(Date:9/1/2015)... ... September 01, 2015 , ... ... announced today that the National Institutes of Health (NIH) has awarded the company ... administered by the NIH’s National Institute of Diabetes and Digestive and Kidney Diseases. ...
Breaking Biology Technology:Fastec Introduces the Quad-HD TS5-Q High-Speed Camera 2Fastec Introduces the Quad-HD TS5-Q High-Speed Camera 3Spirax Sarco Announces New Features to Anytime Platform 2September Is Prostate Cancer Awareness Month 2September Is Prostate Cancer Awareness Month 3September Is Prostate Cancer Awareness Month 4AxioMx Announces Receipt of SBIR Grant for DNA-Protein Complex Antigen Development 2AxioMx Announces Receipt of SBIR Grant for DNA-Protein Complex Antigen Development 3
... on target drug delivery. , ... Cary, NC (PRWEB) ... Inc. company ) and Auburn University announced today a joint research ... of Veterinary Medicine,s Department of Pathobiology, the six-month study is under ...
... State will receive $5 million over four years ... National Center for Nanotechnology Applications and Career Knowledge ... leader in nanotechnology education and workforce development since ... home to the NSF Regional Center for Nanofabrication ...
... Dr. DAVID HARDY, TO DISCUSS CLINICAL USE OF THE, TROFILE(TM) ... ... SOUTH SAN FRANCISCO, Calif., Oct. 23 Monogram,Biosciences, Inc., ... conference,call on Monday, October 27, 2008 at 4:30 p.m. (Eastern ...
Cached Biology Technology:Calvert Research and Auburn University Announce Joint Venture 2Calvert Research and Auburn University Announce Joint Venture 3Penn State gets $5M NSF grant for Nanotech Applications and Career Knowledge 2Monogram Announces Conference Call 2
(Date:8/18/2015)... , Aug. 18, 2015  Navitas ... key contributor to the Submission Content Management ... IRISS, a non-profit forum. Dedicated to the Implementation ... a neutral platform for industry, vendors, health ... information and work towards a standard method ...
(Date:8/12/2015)... NEW YORK , Aug. 12, 2015 /PRNewswire/ ... how hackers can attack Android phones to steal ... identifies the increasing availability of fingerprint scanners on ... of utmost concern. To secure biometrics on mobile ... platform to augment these convenient authentication systems with ...
(Date:8/6/2015)... Calif. , Aug. 6, 2015  Today, ... will visit Crossmatch ™ to learn firsthand ... and protect data. Crossmatch is a world leader ... technologies and expertise are helping federal agencies and ... and security.   "The vast majority ...
Breaking Biology News(10 mins):Navitas, a Key Contributor in IRISS Forum Webinar 2Navitas, a Key Contributor in IRISS Forum Webinar 3HYPR Corp. Addresses Android Vulnerability That Exposes Ecosystem-wide Biometric Security Challenges 2HYPR Corp. Addresses Android Vulnerability That Exposes Ecosystem-wide Biometric Security Challenges 3Rep. Honda to Visit Crossmatch in Redwood City 2
... more than three times as many mutations from their fathers ... father,s age but not the mother,s, researchers have found in ... The study, based on the DNA of around 85,000 Icelanders, ... providing estimates of when human ancestors diverged from nonhuman primates. ...
... have many functions in the central nervous system, such ... the brain,s response to neurotrauma or stroke. ... with collaborators have earlier demonstrated that astrocytes reduce the ... of transplanted neural stem cells can be largely improved ...
... (August 23, 2012) University of Minnesota Medical School ... from Genentech, Inc., to discover how some proteins may ... The proteins part of R-spondin family normally ... of Minnesota researchers have discovered that when two types ...
Cached Biology News:Most mutations come from dad 2Most mutations come from dad 3Astrocytes control the generation of new neurons from neural stem cells 2U of M researchers: Newly discovered genetic markers could signal colon cancer development 2
Request Info...
... TURBO DNase (patent pending) was developed using ... changes into the DNA binding pocket of wild-type ... of the protein for DNA. The result is ... Km for DNA, and an ability to maintain ...
Request Info...
Request Info...
Biology Products: