Navigation Links
Cephalon Submits New Drug Application for TREANDA for the Treatment of Chronic Lymphocytic Leukemia
Date:9/21/2007

FRAZER, Pa., Sept. 21 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) requesting approval of TREANDA(R) (bendamustine HCl) for the treatment of patients with chronic lymphocytic leukemia (CLL). CLL is a slowly progressing blood and bone marrow disease with an estimated 15,000 new cases diagnosed every year in the United States, according to the National Cancer Institute. If approved, TREANDA would be the first new therapy approved by the FDA for the treatment of CLL since 2001. In August 2007, the FDA granted orphan drug designation to TREANDA for this indication.

"This is our first regulatory filing for TREANDA and a significant milestone for our growing oncology portfolio," said Dr. Lesley Russell, Executive Vice President, Worldwide Medical and Regulatory Operations. "We also are developing TREANDA for the treatment of non-Hodgkin's lymphoma and are planning additional submissions for Cephalon oncology compounds to the FDA over the next 12 months."

The NDA is based on a large, international multi-center Phase 3 clinical trial that evaluated the safety and efficacy of bendamustine HCl, the active ingredient in TREANDA, compared to chlorambucil in patients who were not previously treated for their disease. Chlorambucil is an FDA-approved first- line therapy for patients with CLL. In the pivotal trial, bendamustine HCl met both primary endpoints, overall response and progression-free survival and demonstrated an acceptable tolerability profile. The company anticipates that results from this study will be released at the upcoming American Society of Hematology (ASH) annual meeting in December 2007.

The company also is studying TREANDA for the treatment of patients with indolent (or slowly-progressing) non-Hodgkin's lymphoma (NHL), who are refractory to the monoclonal antibody rituximab. Pending positive results from this o
'/>"/>

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

Page: 1 2 3 4

Related biology technology :

1. A Versatile Power Supply for All Electrophoresis Applications
2. Highest Possible Transformation Efficiencies for High-Throughput Applications
3. Unique DNA Polymerase Formulation Excels in a Broad Range of PCR Applications
4. High-Throughput System Generates Ultra-Pure PCR Products Suitable for All Applications
5. An Assessment of the Eppendorf twin.tec plate performance in PCR* applications
6. Principles and applications of electrical cell fusion
7. Eppendorf Electroporation Application Notes Your participation is highly welcome !!!
8. Optimizing Büchi® Rotary Evaporator Applications
9. Principles and applications of electrical cell fusion
10. Eppendorf Electroporation Application Notes Your participation is highly welcome !!!
11. Optimizing Büchi® Rotary Evaporator Applications
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/5/2008)... Dec. 5 Genomic Health,...ompany will present results from,four studies at ...m, taking,place December 10-14, 2008, at the Henr...ies analyze Oncotype DX(R), the company,s multi-ge...to predict the likelihood of chemotherapy,benefit...
(Date:12/5/2008)...nd JERSEY CITY, New Jersey, December 5,/PRNewswir...ROSG ), an,innovative molecular diagnostic compan...day its consolidated financial results for the qua...ghts. , The company recorded revenues for t...ues were recorded from the date of acquisition of ...
(Date:12/4/2008)... Medivation, Inc.,(Nasd..., president and chief,executive officer, will be ...l,Markets 2008 Healthcare Conference on Thursday,...attle Against Cancer" from 8:00-8:55 a.m. Eastern ..." from 12:00-12:55 p.m. Eastern, Time, ,...
(Date:12/4/2008)...witzerland, Dec. 4 Octapharma,Cha...is D. Curtin has been,selected to lead Octapharma...,had been Octapharma,s U.S. legal counsel since 20...eutics, Inc. , The largest private plasma p... acquired Life Therapeutics, the Atlanta company t...
Breaking Biology Technology:Genomic Health to Present Multiple New Studies at 31st Annual San Antonio Breast Cancer Symposium 2Genomic Health to Present Multiple New Studies at 31st Annual San Antonio Breast Cancer Symposium 3Rosetta Genomics Reports Third Quarter 2008 Financial Results; Records First Revenues of $705,000; $7.4 Million Added to Available Cash Due to Repurchase of ARS 2Rosetta Genomics Reports Third Quarter 2008 Financial Results; Records First Revenues of $705,000; $7.4 Million Added to Available Cash Due to Repurchase of ARS 3Rosetta Genomics Reports Third Quarter 2008 Financial Results; Records First Revenues of $705,000; $7.4 Million Added to Available Cash Due to Repurchase of ARS 4Rosetta Genomics Reports Third Quarter 2008 Financial Results; Records First Revenues of $705,000; $7.4 Million Added to Available Cash Due to Repurchase of ARS 5Rosetta Genomics Reports Third Quarter 2008 Financial Results; Records First Revenues of $705,000; $7.4 Million Added to Available Cash Due to Repurchase of ARS 6Rosetta Genomics Reports Third Quarter 2008 Financial Results; Records First Revenues of $705,000; $7.4 Million Added to Available Cash Due to Repurchase of ARS 7Rosetta Genomics Reports Third Quarter 2008 Financial Results; Records First Revenues of $705,000; $7.4 Million Added to Available Cash Due to Repurchase of ARS 8Rosetta Genomics Reports Third Quarter 2008 Financial Results; Records First Revenues of $705,000; $7.4 Million Added to Available Cash Due to Repurchase of ARS 9Rosetta Genomics Reports Third Quarter 2008 Financial Results; Records First Revenues of $705,000; $7.4 Million Added to Available Cash Due to Repurchase of ARS 10Medivation Announces Participation in RBC Capital Markets 2008 Healthcare Conference 2Octapharma Names Dennis D. Curtin To Lead U.S. Plasma Operations 2
...e big enough that no one is likely to see everythi...es where they,ll be during the marathon event that...this April 9 through 12. Here,s a sampling of thei...e applied to present as part of the Business Forum...ting and opportunities for companies to meet with ...
...1,000 scholarships and a top prize of $7,500 in se... in a business-plan competition sponsored by BizF...he Young Entrepreneur Foundation . , ,The contest...from U.S. college and high-school students until M..., , Young Entrepreneur Foundation: Contest guidel...
...s Bio Corporation says its scientists have develo...ly. , ,Antibodies, naturally part of the immune sy...iseases and for diagnostics or research. Mirus, ne...oTechniques, involves intravenously injecting DNA ...ibodies that are harvested and used. , ,According ...
...nt Lawrence H. Summers created a firestorm last ye...ion in math and science fields might be the result... women. While that comment may be only part of the..., it focused the spotlight on the need for more di..., diversity in top IT positions has a way to go, b...
Other Biology Technology:Where will you be at BIO? 2Diversity still an elusive goal in IT, other tech fields 2Diversity still an elusive goal in IT, other tech fields 3
(Date:12/4/2008)...ech Wake Forest University,s School of Biomedical...chanics has received the Army Modeling and Simulat...Chief of Staff of the Army and Director of the Arm...mately help save eyesight and reduce morbidity and... center was selected from 57 applicants from aroun...
(Date:12/4/2008)... looking for bonefish from Miami down to the Marqu...m, and that is down slightly from the average of p...ion among those who are counting, researchers spec... of Marine and Atmospheric Science held the sixth ...n with the conservation group Bonefish & Tarpon Un...
(Date:12/4/2008)... carry weight in the thighs and backside have been...re and heart disease than apple-shaped people who ...trition researchers at Washington University Schoo...arisons don,t completely explain risk. , In two ...e the real key to insulin resistance, cholesterol ...
(Date:12/4/2008)...ated with higher levels of omega-3 fatty acids in ...ing of the European study IMMIDIET that will be pu...nal of Clinical Nutriti on, an official publicatio...eady available on line ( www.ajcn.org ). The stud...lic drinks. This effect could be ascribed to compo...
Breaking Biology News(10 mins):New dummy design and development wins US Department of Defense award 2Bonefish census reveals population holding steady 2Apple or pear shape is not main culprit to heart woes -- it's liver fat 2A little wine boosts omega-3 in the body: Researchers find a novel mechanism for a healthier heart 2A little wine boosts omega-3 in the body: Researchers find a novel mechanism for a healthier heart 3PPD Reports Fourth Quarter and Year End 2007 Financial Results 11214 1PPD Reports Fourth Quarter and Year End 2007 Financial Results 11214 2PPD Reports Fourth Quarter and Year End 2007 Financial Results 11214 3PPD Reports Fourth Quarter and Year End 2007 Financial Results 11214 4PPD Reports Fourth Quarter and Year End 2007 Financial Results 11214 5PPD Reports Fourth Quarter and Year End 2007 Financial Results 11214 6Inverness Medical Innovations to Present at 2008 UBS Global Healthcare Services Conference on February 13 2008 11209 1Inverness Medical Innovations to Present at 2008 UBS Global Healthcare Services Conference on February 13 2008 11209 2Exelixis Announces February 12 Webcast of Presentation at the 10th Annual BIO CEO and Investor Conference 3088 1New Report Offers Comprehensive Look at Mental Health in Minnesota 11205 1New Report Offers Comprehensive Look at Mental Health in Minnesota 11205 2
...d that our brains fend off distractions. If we are...al influences. If we are tired, we can no longer d...the brain selects incoming information to remember... and neutral information may enter. In the event o... , Test , Psychologists carry out a lot of...
...ks a form of blood cancer in mice by engineering a...rtening the ends of chromosomes, called telomeres.... the cell commits suicide as a means of protecting...Nathans chair of molecular biology and genetics at...onth at Cancer Cell, uncovers an alternate respons...
...agen have demonstrated that the spinal cord use ne...n. The discovery is featured in the current issue ...ising results consists of Professor Jørn Hounsgaar... Copenhagen, and Assistant Professor and PhD Aidas...p has shown that spinal neurons, during network ac...
...f millions of hours of work productivity this spri...ver symptoms, including sneezing, watery eyes and ...n hour of work per week during peak hay fever seas...seem small, consider that 20 to 50 million America...ay fever, or allergic rhinitis, said Sheryl Szeinb...
Other Biology News:Brain fends off distractions 2Short chromosomes put cancer cells in forced rest 2Hay fever can send work productivity down the drain 2Hay fever can send work productivity down the drain 3
Zymoclean Gel DNA Recovery Kit from Zymo Research
Collected from 8-12 week-old New Zealand or Californian rabbits.,Supplied in lyophilized form.
DeadEnd Fluorometric TUNEL System from Promega
Agarose overlays are commonly used in baculovirus plaque assays. Many commercial "DNA grade" agaroses either contain contaminants that are toxic to insect cells or lack the physical characteristics r
Biology Products: