Navigation Links
TREANDA New Drug Application for the Treatment of Chronic Lymphocytic Leukemia Granted Priority Review Status by FDA
Date:12/3/2007

FRAZER, Pa., Dec. 3 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review designation to the TREANDA(R) (bendamustine HCl) New Drug Application (NDA) for the first-line 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. Cephalon filed the TREANDA NDA for CLL in September 2007 and the FDA will make a review decision by the end of March 2008.

"If approved, TREANDA will make a meaningful difference as the first new CLL treatment option approved by the FDA since 2001 and could be available as soon as the second quarter of 2008," said Dr. Lesley Russell, Executive Vice President, Worldwide Medical and Regulatory Operations.

The FDA assigns priority review to drugs that, if approved, would offer major advances in treatment or would provide treatment to patients where no adequate therapy exists. Priority review reduces the targeted NDA review time from 10 months to six months. FDA granted orphan drug status for TREANDA for CLL in August 2007, which would entitle Cephalon to a seven-year period of marketing exclusivity in the United States, if the product is approved for this indication.

About TREANDA

TREANDA is a rationally designed purine analog/alkylator hybrid. Preclinical data demonstrate that this rationally designed hybrid acts in two ways to kill cancer cells. TREANDA damages the DNA in cancer cells, which leads to the normal path of cell death (apoptosis). It also stops cancer cells from dividing to create new cancer cells. This dual-action of TREANDA may be attributable to its unique chemical design.

Cephalon holds exclusive rights to market and develop TREANDA in the United States. TREANDA is licensed from Astellas Pharma GmbH. Bendamustine HCl, the active ingredient in
'/>"/>

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

Page: 1 2 3 4 5

Related medicine news :

1. Cephalon Submits New Drug Application for TREANDA for the Treatment of Chronic Lymphocytic Leukemia
2. Schering-Plough/Merck Pharmaceuticals Announce FDA Filing Acceptance of New Drug Application for Loratadine/Montelukast Tablet
3. Investigational New Drug Application for Fat Melting Injections Cleared by the FDA
4. PreMD Provides Update on 510(k) Application for PREVU(x) POC
5. Mindray Selects Actel Low-Power Flash FPGAs for Demanding Medical Equipment Applications
6. Medical Services International Inc. Completes Testing for European Union (EU) Application
7. Pharsight Files Application for Nasdaq Capital Market Listing
8. PartsSource Awarded US Patent for PartsFinder(TM) Application
9. HealthCentral.com Launches Greeting Card Application on Facebook.com
10. FDA Accepts New Drug Application for Priority Review of Investigational HIV Treatment TMC125
11. FDA Accepts New Drug Application for Priority Review of Investigational HIV Treatment TMC125
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/22/2015)... VA (PRWEB) May 22, 2015 ... presented at the American Society of Clinical Oncology ... demonstrated improved survival rates for those patients who ... chemotherapy regimen of pemetrexed/cisplatin. Bevacizumab (Avastin® Genentech, Inc.) ... growth), and it is already routinely used to ...
(Date:5/22/2015)... 2015 Wimbledon Health Partners, the leading ... echocardiogram and NCV testing , is proud to ... All American National athlete, to the Wimbledon Athletics division. ... high level of testing and information it provides to ... athletic trainers, this way they can focus on the ...
(Date:5/22/2015)... 22, 2015 DMG Productions announces the ... to broadcast on Friday, May 29, 2015 at 7:30 ... , In this episode Innovations will explore Interstate Restoration, ... business quickly through disaster recovery and restoration. , Additionally, ... works collaboratively to develop and deliver training and education ...
(Date:5/22/2015)... 22, 2015 Ticket Down is a reputable ... Rangers NHL Eastern Conference Finals Tickets . All seating ... otherwise in the ticket listing. , For the first ... the top of the Eastern Conference. One of the original ... of ups and downs over the years, but the excitement ...
(Date:5/22/2015)... May 22, 2015 In an effort ... and Sons is offering to donate $5 dollars for ... AC unit or water softening system. Customers have their ... and Sons gets business; and the Special Olympics receives ... Special Olympics helps over 4.4 million athletes, and boasts ...
Breaking Medicine News(10 mins):Health News:Mesothelioma Research Organization Excited About Imminent Improvement to Standard of Care 2Health News:Wimbledon Athletics Recruits Team USA Athlete 2Health News:Wimbledon Athletics Recruits Team USA Athlete 3Health News:New Episode of Innovations Airing Friday, May 29, 2015 Via Discovery Channel 2Health News:Cheap Lightning vs Rangers NHL Eastern Conference Finals Tickets: Ticket Down Slashes Ticket Prices on New York Rangers vs Tampa Bay Lightning Eastern Conference Playoffs 2Health News:Cheap Lightning vs Rangers NHL Eastern Conference Finals Tickets: Ticket Down Slashes Ticket Prices on New York Rangers vs Tampa Bay Lightning Eastern Conference Playoffs 3Health News:Parker and Sons is Proud to Support the Special Olympics with Their Everybody Wins Program 2
... -- There,s no link between menopause and increased risk ... challenges a long-held medical belief that the rate of ... alone, not the hormonal impact of menopause, explains the ... the Johns Hopkins researchers. The new findings could ...
... Johns Hopkins researchers say data show aging alone, not hormonal ... age Contradicting the long-held medical belief that the ... new research from Johns Hopkins suggests instead that heart disease ... they age. The findings, published in BMJ ...
... published in the Archives of General Psychiatry suggest that certain ... chemical related to mood), may serve as a useful predictor ... following a trauma. "One of the critical questions ... developing the disorder following a trauma, while others appear to ...
... -- Many teens with autism rely on school-based mental health ... a 10-year study of more than 920 adolescents with an ... participants were aged 13 to 17 when the study began ... with autism used a mental health service in the past ...
... (HealthDay News) --,Dental injuries are all too common among ... expert says. "Basketball and baseball are the two ... see are broken, displaced or knocked out teeth, and ... pediatric dentistry department at the University of Alabama at ...
... 2 (HealthDay News) -- Having weight loss surgery before breast ... both procedures, according to a small new study. While ... -- including reduced pain and increased ability to exercise -- ... after they lose large amounts of weight, Dr. Jeffrey Gusenoff ...
Cached Medicine News:Health News:Aging, Not Menopause, Raises Women's Heart Risks, Study Finds 2Health News:Study: No link betweem menopause and increased risk of fatal heart 2Health News:Study: No link betweem menopause and increased risk of fatal heart 3Health News:The search for predictors of risk for PTSD 2Health News:Toothless Grins Are Only Cute on Babies 2Health News:Is Breast Reduction After Weight Loss Surgery Best? 2
(Date:5/21/2015)... Md. , May 21, 2015 ... open innovation competition designed to bring promising medical ... Heritage Provider Network (HPN) in collaboration with the ... for Advancing Innovation (CAI).  The winning teams were ... and live pitches and will move forward to ...
(Date:5/21/2015)... CITY, Calif. , May 21, 2015  Abaxis, ... manufacturing point-of-care blood analysis systems, announced today that ... investor relations, transitioning into the role of chief financial ... Stifel 2015 Dental & Veterinary Conference on Wednesday, May ... be held at The Peninsula Hotel in ...
(Date:5/21/2015)... , May 21, 2015 Frost & ... two-thirds of laboratories use commercial software or web-based ... represents uncaptured market share for suppliers. With 26 ... custom systems in-house, it is clear that various ... indicates that suppliers have a chance to gain ...
Breaking Medicine Technology:Neuro Startup Challenge selects 13 winning teams to launch startups for unlicensed NIH technologies to improve brain health 2Neuro Startup Challenge selects 13 winning teams to launch startups for unlicensed NIH technologies to improve brain health 3Neuro Startup Challenge selects 13 winning teams to launch startups for unlicensed NIH technologies to improve brain health 4Customers' Unmet Needs Create Opportunities for Laboratory Information Management System Suppliers to Transform the Industry 2Customers' Unmet Needs Create Opportunities for Laboratory Information Management System Suppliers to Transform the Industry 3Customers' Unmet Needs Create Opportunities for Laboratory Information Management System Suppliers to Transform the Industry 4
... , TELFORD, Pa. , Feb. 4 ... 16 ventilators and two anesthesia machines to the University of ... room suites. , Draeger, a global leader in mechanical ventilation, ... earthquake victims.  This donation comes at the request of the ...
... , SAN ANTONIO , Feb. ... of Pain Medicine,s 26th Annual Meeting provides early published ... monitoring program, known as the Controlled Substances Utilization Review ... increase in the likelihood of individuals receiving opioids from ...
Cached Medicine Technology:Draeger Donating Mechanical Ventilators and Anesthesia Machines to University of Miami - Aid for Haiti Earthquake Disaster 2New Research Gives Insight to the Frequency of 'Doctor Shopping' Occurring Within Prescription Monitoring Programs 2New Research Gives Insight to the Frequency of 'Doctor Shopping' Occurring Within Prescription Monitoring Programs 3
... 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 ...
... 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 ...
... 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 ...
Medicine Products: