Navigation Links
FDA Indicates That Genasense(R) Approval in Chronic Lymphocytic Leukemia Will Require Additional Confirmatory Data
Date:3/17/2008

eutical Development, and Chief Medical Officer. "Our approach mirrors our strategy for Genasense in melanoma in which a smaller Phase 3 trial, expected to complete accrual later this year, seeks to confirm efficacy by focusing on patients who derived maximum benefit in a large randomized trial. In parallel with collection and analysis of existing data in CLL, Genta has developed a new clinical trial, and the Company will file its draft protocol seeking formal Scientific Advice at the May meeting of the European Medicines Agency (EMEA). Genta greatly appreciates the professional and collaborative communications with FDA during this process, and we look forward to working closely with FDA in addressing their recommended options for securing the confirmatory data."

Proposed Confirmatory Trial of Genasense in CLL

The proposed protocol, based on results obtained during the previous trial, is a randomized controlled trial at first or second relapse in patients who are "non-refractory". All patients will receive fludarabine plus cyclophosphamide (Flu/Cy) - an accepted standard of care - and they will be randomly assigned to receive Genasense or no additional therapy. The trial will seek to confirm that the addition of Genasense increases complete responses (CR) in patients who receive Flu/Cy chemotherapy.

In the preceding Phase 3 trial, 241 patients with relapsed or refractory CLL were randomly assigned to receive Flu/Cy with or without Genasense. This study achieved its primary endpoint - an increase in the proportion of patients who achieved CR (17% vs. 7%; P=0.025). By definition, CR represents the complete elimination of all clinical signs of leukemia, combined with the elimination of leukemia-related symptoms. The duration of CR was also significantly longer for patients treated with Genasense (i.e., median not yet reached but exceeding 36 months in the Genasense group compared with 22 months for the Flu/Cy-only group).

In patients predefin
'/>"/>

SOURCE Genta Incorporated
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine technology :

1. FDA Extends Review of Genasense(R) NDA Appeal in Chronic Lymphocytic Leukemia
2. FDA to Extend Review of Data Quality Submission for Genasense(R) in Melanoma
3. Genasense(R) Data in Patients with Advanced Melanoma to be Featured at 4th International Melanoma Congress
4. Genasense(R) Can be Administered by Brief High-Dose IV Infusion
5. Authorization for AGENDA Phase 3 Trial of Genasense(R) in Advanced Melanoma Granted by French Regulatory Agency
6. Genasense(R) Data in Melanoma to be Presented in Opening Session at First Worldwide Melanoma Center Meeting of the European Association of Dermato-Oncology
7. Genta Initiates Phase 3 AGENDA Trial of Genasense(R) for Patients with Advanced Melanoma
8. FDA Advisory Committee Unanimously Recommends U.S. Approval of Sugammadex, the First and Only Selective Relaxant Binding Agent
9. CSL Behring Submits BLA Requesting Approval of C1-Esterase Inhibitor for the Treatment of Hereditary Angioedema
10. DuraHeart(TM) LVAS Receives Conditional Approval for US Pivotal Trial
11. Arbios Receives Conditional Approval from the FDA to Initiate Pivotal Clinical Trial for SEPET(TM)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/19/2014)... France , Dec. 19, 2014  Eli Lilly ... (Euronext Paris: FR0011184241 – ADOC) today announced a worldwide ... as BioChaperone Lispro, for treatment in people with type ... Adocia,s proprietary BioChaperone® technology and is currently in Phase ... BioChaperone Lispro with the goal of optimizing glucose levels ...
(Date:12/17/2014)... 2014 Revenue and earnings above the ... and development In the past 2013/14 fiscal year ... percent to EUR 4.287 billion (last year: EUR 4.190 billion) ... to EUR 360 million. "Overall, 2013/14 was a successful fiscal ... , President and CEO of Carl Zeiss AG. "Thanks to ...
(Date:12/17/2014)... , Dec. 17, 2014  Beamz Interactive, ... interactive music products, today announced that it has ... leading manufacturer and supplier of innovative prosthetic, orthotic ... As part of the agreement, RSL Steeper will ... solution specifically configured for use within UK residential ...
Breaking Medicine Technology:Lilly and Adocia Announce Alliance to Co-Develop Ultra-Rapid Insulin Based on BioChaperone Technology 2Lilly and Adocia Announce Alliance to Co-Develop Ultra-Rapid Insulin Based on BioChaperone Technology 3ZEISS Asserts its Position in Difficult Environment 2Beamz Interactive, Inc. Signs UK Distribution Agreement with RSL Steeper Limited 2Beamz Interactive, Inc. Signs UK Distribution Agreement with RSL Steeper Limited 3
... Sutro Biopharma, a biopharmaceutical company developing both ... properties, today announced that it has appointed Trevor ... Hallam will lead Sutro,s ongoing efforts in the ... platform for the research and development of novel ...
... 8, 2010 /PRNewswire-Asia/ -- From the 1st to the ... developed world will meet at Vaccine World Summit in ... in partnership with DCVMN (Developing Countries Vaccine Manufacturers Network). ... global public health challenges including appropriate pandemic surveillance programs, ...
Cached Medicine Technology:Sutro Biopharma Appoints Trevor Hallam, Ph.D., as Chief Scientific Officer 2World Vaccine Leaders to Meet in New Delhi India to Tackle Global Public Health Challenges 2
(Date:12/20/2014)... December 21, 2014 BambooIndustry.com is ... Recently, the business has announced its bamboo flooring ... the best material from certified suppliers, and offers ... customers worldwide. In the current promotion, all customers ... off, when they say they know BambooIndustry.com from ...
(Date:12/20/2014)... December 20, 2014 Dress company LunaDress has ... and announced its Christmas Sale, offering big discounts on all ... girl has an idea to own a perfect wedding gown. ... your wedding dress, then come to LunaDress. Many different wedding ... you. Visit our website now and enjoy the current special ...
(Date:12/20/2014)... VogueQueen.com, a leading wedding dress wholesaler and retailer, has ... 2015. Great discounts are now offered on all of ... a discount, up to 80% off, when they place ... 2015. , VogueQueen.com has recently released its new arrival ... Many customers worldwide like VogueQueen’s special designs which feature ...
(Date:12/20/2014)... 20, 2014 Atore, Inc, (San Francisco, ... launched first birthday focused portal on December 17th, 2014. ... launched in both US and Japan. , MERRY BIRTHDAY ... http://merrybirthday.net/message/ , MERRY BIRTHDAY MESSAGE is part ... the world. , Features, Choose from thousands of stock ...
(Date:12/20/2014)... Columbus, OH (PRWEB) December 20, 2014 ... contend they suffered uncontrollable bleeding and other ... District Court, Eastern District of Louisiana for coordinated pretrial ... Panel on Multidistrict Litigation (JPML) issued an order Friday ... tag-along actions pending in 22 federal courts to the ...
Breaking Medicine News(10 mins):Health News:Eco-friendy Bamboo Flooring Manufacturer BambooIndustry.com Introduces Its Bamboo Flooring Promotion for 2015 2Health News:2015 Collection of Wedding Dresses from LunaDress Online on Sale Now 2Health News:VogueQueen Big Sale Online For The Coming 2015 2Health News:Atore, Inc. Releasing the First Birthday Portal 2Health News:Xarelto Bleeding Lawsuits Consolidated To Louisiana Federal Court For Multi-District Litigation Reports Wright & Schulte LLC 2Health News:Xarelto Bleeding Lawsuits Consolidated To Louisiana Federal Court For Multi-District Litigation Reports Wright & Schulte LLC 3Health News:Xarelto Bleeding Lawsuits Consolidated To Louisiana Federal Court For Multi-District Litigation Reports Wright & Schulte LLC 4
... patients could benefit from similar,improvements, DALLAS, ... article published today, "An organized approach to ... presented the first,head-to-head comparison of quality medical ... Disease (GWTG-CAD) hospitals vs. other US,hospitals not ...
... PITTSBURGH, Sept. 8 Mylan Inc. (NYSE: ... to market and other,conditions, $400 million principal amount ... offering to qualified institutional buyers pursuant,to Rule 144A ... (the "Securities,Act"). Mylan also expects to grant the ...
... States Agency for International Development (USAID) has awarded the ... at Chapel Hill up to $181 million to continue ... largest ever received by UNC. , The award funds ... child health, nutrition and HIV/AIDS programs around the world. ...
... Menopausal women who take hormones face greater chance of ... -- Women who take hormones to relieve symptoms of ... gastroesophageal reflux disease (GERD). , Also, women who use ... cancer and osteoporosis, also have a higher risk of ...
... Sept. 8 The nation faces,challenges in utilizing ... health, according to a NASA-sponsored report issued Monday,by ... report examines the computer-based decision support tools that ... in areas such as,agricultural productivity, air quality, renewable ...
... Sunday, Sept 14, 2008, WHERE: Moscone South Convention Center ... Francisco, CA 94103, and, ... 55 4th Street San Francisco, CA 94103, ... Nickols (916) 704-8965, WHAT: Approximately 15,000 dentists and dental professionals are ...
Cached Medicine News:Health News:Hospitals Participating in Get With The Guidelines(SM) Program Follow Heart Attack Treatment Guidelines Better Than Others 2Health News:Mylan to Offer $400 Million in Cash Convertible Notes 2Health News:Mylan to Offer $400 Million in Cash Convertible Notes 3Health News:UNC receives record $181 million grant to evaluate health, poverty and gender programs worldwide 2Health News:HRT Use Raises Risk of Stomach Trouble 2Health News:HRT Use Raises Risk of Stomach Trouble 3Health News:Report Explores Use of Earth Data to Support National Priorities 2Health News:Report Explores Use of Earth Data to Support National Priorities 3Health News:Renowned Dentists to Present Latest on Dental Innovations 2Health News:Renowned Dentists to Present Latest on Dental Innovations 3
... Bledsoe Sport & Sport Max patellofemoral knee ... and/or collateral injuries. Patients with minor knee ... can benefit from added support to prevent ... designs to provide the right kind of ...
... Brace gives fracture treatment patients maximum support ... brace features the the Bledsoe Multi-Centric Hinge, ... and positively locks at any angle within ... slots, the Bledsoe Multi-Centric Hinge anatomically tracks ...
... The Bledsoe Revolution ... for speed fitting under ... frees the surgeon or ... time-consuming post-op fitting and ...
The Bledsoe Post-Op Knee Brace is designed to provide maximum protection without sacrificing comfort and quick, easy application....
Medicine Products: