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:10/20/2014)... Richardson, Texas (PRWEB) October 20, 2014 ... today announced that a team from Iowa State University ... * design contest. Using a Convey HC-2ex, the team’s ... than 14 times faster than the second place finisher. ... academic world embarked upon the month long challenge, using ...
(Date:10/20/2014)...  GenVec, Inc. (NASDAQ: GNVC ) today announced ... its board of directors effective on October 24, 2014.   Dr. ... as its chairman from June 2006 to November 2013.  During ... Governance and Audit Committees of the board.  ... dedicated service to GenVec, and its stockholders," said Wayne ...
(Date:10/20/2014)... OR (PRWEB) October 20, 2014 Local ... participate in an investigational study of donor stem cells ... in stem cell therapy and has performed clinical stem ... this study is to determine if a single injection ... affected joints can help reduce pain and inflammation in ...
(Date:10/19/2014)... (PRWEB) October 19, 2014 The ... bromine market in Asia-Pacific with analysis and forecast ... the Asia Pacific Bromine Market report, to get ... also provides a glimpse of the segmentation in ... various tables and figures. , http://www.micromarketmonitor.com/market/asia-pacific-bromine-6741503144.html ...
Breaking Biology Technology:Team from Iowa State Wins 2014 MemoCODE Design Contest Using Convey HC-2ex 2Team from Iowa State Wins 2014 MemoCODE Design Contest Using Convey HC-2ex 3Zola P. Horovitz To Retire From GenVec Board 2Cascade Veterinary Referral Center Seeks Candidates for an Investigational Study of Stem Cells for Dogs with Arthritis 2The Asia-Pacific Bromine Market is estimated to grow to $4,080.1 million by 2018 - New Report by MicroMarket Monitor 2The Asia-Pacific Bromine Market is estimated to grow to $4,080.1 million by 2018 - New Report by MicroMarket Monitor 3
... , , , , , ... , , , , The ability ... means that trace amounts of DNA contaminants could serve as templates, resulting , ... mentioned below to avoid PCR contamination from sources such as: , ...
... , , , , , , ... are three types of primers that may be used for reverse transcription: , ... poly(A) + tail , at the 3' end of mammalian mRNA. ... , Random hexanucleotides, which bind ...
... , , , ... a billionfold. Thus, even minuscule amounts of a contaminant can ... positive result. Such contaminants are often products , ... researchers have developed methods to avoid such contamination. , ...
Cached Biology Technology:Setting up the laboratory to avoid contamination 2Preventing Carry-over Contamination with Uracil-DNA Glycosylase 2
(Date:10/22/2014)... , Oct. 20, 2014  Leading identity analyst firm ... half of the world,s population will have a chip-based ... Europe . Asia , ... market accounting for more than 60% of all National ... Acuity,s report  -- "The Global National eID ...
(Date:10/18/2014)... for evaluation of suspected genetic conditions, whole-exome sequencing ... including detection of a number of rare genetic ... to a study appearing in JAMA . ... the American Society of Human Genetics annual meeting. ... regions of thousands of genes simultaneously using next-generation ...
(Date:10/17/2014)... Copenhagen have shown for the first time how bacteria ... patients, giving them the opportunity to get tremendous insights ... The study also discovered the bacterial growth in chronic ... or slowed down by the immune cells. The researchers ... helped "suffocate" the bacteria, forcing the bacteria to switch ...
Breaking Biology News(10 mins):Half the World's Population Will Have Chip-Based National Electronic Identity (eID) Cards by 2018 2Whole-exome sequencing shows potential as diagnostic tool 2Scientists opens black box on bacterial growth in cystic fibrosis lung infection 2
... Torriani is a plant pathologist. His most recent research ... where he analyzed a special class of genes that ... heavily on these enzymes when attacking a plant. But ... one gene came in different sizes in different individuals. ...
... A team of scientists from Worcester Polytechnic Institute ... Life Sciences and Bioengineering Center, have regenerated functional muscle ... clinical therapy to treat people who suffer major muscle ... coax mature human muscle cells into a stem cell-like ...
... Adelaide scientist says much more could be done to predict ... tuberculosis (TB) or foot-and-mouth disease - in Australian wildlife and ... have evaluated freely available software tools that provide a realistic ... used a combination of models to look at the possible ...
Cached Biology News:Shedding light on the 'dark matter' of the genome 2Shedding light on the 'dark matter' of the genome 3Shedding light on the 'dark matter' of the genome 4Body rebuilding: Researchers regenerate muscle in mice 2Body rebuilding: Researchers regenerate muscle in mice 3New thinking required on wildlife disease 2
assays for phosphatase, lipase, nucleoside triphosphatases (ATPase, GTPase etc). HTS and follow up studies for phosphatase inhibitors. Quantitation of phosphate content in protein, lipids, and DNA....
... with Purpose -- The Varian ... the highest level of flexibility ... an affordable, easy-to-use system. The ... workstation guarantees success with today's ...
Homo sapiens 4-aminobutyrate aminotransferase Antigen: Recombinant Protein...
Human DCIR/CLEC4A Phycoerythrin MAb (Clone 216110)...
Biology Products: