Navigation Links
Cephalon Submits New Drug Application for TREANDA for the Treatment of Chronic Lymphocytic Leukemia
Date:9/22/2007

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 medicine news :

1. Provigil Patent Extension Accorded To Cephalon
2. Novartis files application with FDA for Zometa
3. Morepan to file new drug applications with the USFDA
4. Mini motor for micromedical applications
5. Perfusion bioreactor could enhance stem cell research and application in the future
6. Prostate Cancer Can Be Treated By Application Of LASER Technology
7. Varied Applications of Adult Stem Cells to Treat Host of Disorders in Human
8. Venus Remedies Files 5th International Patent Application
9. NICE supports application of advanced biological therapies as treatment option for acute psoriasis
10. Roche puts in an Application to Use Herceptin for Treatment in Her-2 positive breast cancer
11. New Drug Application Submitted for Investigational Antibiotic Doripenem
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/24/2014)... (PRWEB) July 24, 2014 Members of the ... Wolnerman, RPh, CCIM, Senior Associate of Sales at OutcomesMTM, as ... appointed him to the Board and that his peers chose ... want to provide the best I can for the citizens ... am uniquely positioned to provide a special insight to concerns ...
(Date:7/24/2014)... that it is possible to predict long-term cancer risk from ... same exposure. The findings, which currently appear in the journal ... simpler and cheaper tests to screen chemicals for their potential ... in incidence of and mortality from cancer, about 40 percent ... lifetime, and around 20 percent will die of it. Currently ...
(Date:7/24/2014)... PHILADELPHAA rare procedure occasionally performed during Jewish circumcisions that ... herpes simplex virus type 1 (HSV-1) transmissions documented ... review conducted by Penn Medicine researchers and published ... Disease Society found. The reviewers, from Penn,s ... cases in New York, Canada and Israel. , The ...
(Date:7/24/2014)... who received the Human Papillomavirus Vaccination (HPV) even ... abnormal Pap test results than those who were ... Sexually Transmitted Diseases . , Researchers ... School of Medicine conducted a cross-sectional study of ... cervical cytology testing. HPV status and demographic and ...
(Date:7/24/2014)... According to market research report "3D Mapping Market: ... Analysis - 2018", the 3D mapping and 3D ... by 2018 at a CAGR of 47.9% by ... and 30 figures spread through 222 pages and ... Business Models, Technology Roadmap, Forecasts and Analysis - ...
Breaking Medicine News(10 mins):Health News:Wolnerman Re-elected as Chairperson of Iowa State Board of Health 2Health News:Researchers discover new way to determine cancer risk of chemicals 2Health News:Link between ritual circumcision procedure and herpes infection in infants examined 2Health News:3D Mapping & 3D Modeling Market Projected to $7.7 Billion by 2018 - Report by MarketsandMarkets 2Health News:3D Mapping & 3D Modeling Market Projected to $7.7 Billion by 2018 - Report by MarketsandMarkets 3Health News:3D Mapping & 3D Modeling Market Projected to $7.7 Billion by 2018 - Report by MarketsandMarkets 4
... Migraine sufferers who experienced abuse and neglect ... disease including stroke and myocardial infarction (MI) among others, ... Society,s 52nd Annual Scientific Meeting in Los Angeles this ... than 1,300 headache clinic patients diagnosed with migraine, investigators ...
... 23, 2010) Typically, migraine is considered to be ... But new research by Dr. Till Sprenger and his ... found increased network activity -- stronger functional connectivity -- ... migraineurs. "There has been increasing evidence ...
... New York, NY, June 23, 2010Despite having the most ... overall compared to six other industrialized countriesAustralia, Canada, Germany, ... of health system performance in five areas: quality, efficiency, ... long, healthy, productive lives, according to a new Commonwealth ...
... 2009 release of guidelines that would have reduced use ... highlights challenges for implementing the findings of comparative effectiveness ... challenges which may become more common due to ... the public and stakeholders about evidence and its connection ...
... Jacksonville ... to college freshman in Florida , ... Orlando, Fla. (June 23, 2010) – "Get tested. Get tested. Get ... to families at his first-ever Playmaker 11 Scholarship ceremony hosted by him on June ...
... to stricter standards, experts suggest , TUESDAY, June 22 ... what is currently considered a normal range for thyroid ... face an increased risk for miscarriage as a result, ... to link what has previously been considered normal thyroid ...
Cached Medicine News:Health News:Migraine sufferers who experienced childhood abuse have greater risk of cardiovascular disease 2Health News:US ranks last among 7 countries on health system performance 2Health News:US ranks last among 7 countries on health system performance 3Health News:Implementing comparative effectiveness research: Lessons from the mammography screening controversy 2Health News:NFL Wide Receiver Mike Sims-Walker Remembers His Father by Giving Out Scholarships 2Health News:Thyroid Function at High End of Normal Tied to Miscarriage Risk 2
(Date:7/24/2014)... MENLO PARK, Calif. , July 24, 2014 ... "the company") announced today that the company,s board of directors ... 31 to June 30. Accordingly, DelMar will file a Transition ... Jeffrey Bacha , president and CEO of DelMar stated, ... in achieving our goal of obtaining a senior exchange listing ...
(Date:7/24/2014)... 2014 LSI Medience Corporation today announced ... Kineticos, a Raleigh-Durham, NC ... LSI Medience in identifying opportunities for Presepsin, a ... in clinical trials. The Presepsin biomarker ... of sepsis, prognosis of septic patients, early risk ...
(Date:7/24/2014)... Talyst, a market leader in pharmacy automation, ... State Veterans Homes (NASVH) Summer Conference in ... NASVH is to ensure that each and every eligible ... care and respect which they have earned by their ... Remote Dispensing System, Talyst can help State Veterans Homes ...
Breaking Medicine Technology:DelMar Pharmaceuticals Announces Change of Fiscal Year End and Provides Update on Glioblastoma Clinical Trial 2DelMar Pharmaceuticals Announces Change of Fiscal Year End and Provides Update on Glioblastoma Clinical Trial 3LSI Medience Corporation and Kineticos Sign Agreement Related to the Presepsin Biomarker in Sepsis Management and Treatment 2Talyst Exhibits at the National Association of State Veterans Homes Summer Conference 2
... 8, 2010 /PRNewswire-Asia-FirstCall/ -- Tianyin Pharmaceutical Co., Inc., ... company that develops, manufactures and sells patented biopharmaceutical, ... pharmaceuticals, today announced that the senior management will ... quarter of fiscal year 2011 ending September 30, ...
... Md., Nov. 8, 2010 Substandard and counterfeit versions ... locations across Ghana by the Medicines Quality Monitoring surveillance ... Board (FDB) in collaboration with the U.S. Pharmacopeial Convention ... the program samples antimalarials across the public and private ...
Cached Medicine Technology:Tianyin Pharmaceutical Co., Inc. to Host First Quarter of Fiscal Year 2011 Earnings Conference Call on Thursday, November 11, 2010 at 9:00 a.m. ET 2Substandard and Counterfeit Antimalarial Drugs in Ghana Discovered by Cooperative Program of USP, Ghana Food and Drugs Board 2Substandard and Counterfeit Antimalarial Drugs in Ghana Discovered by Cooperative Program of USP, Ghana Food and Drugs Board 3
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
Medicine Products: