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:12/26/2014)... 2014 Parker & Sons, Inc. ... in heating, cooling and plumbing contractor services throughout ... services in 2014 with regard to air-conditioning systems. ... is known for its incredibly hot summers. Working ... intricacies and details of a wide variety of ...
(Date:12/25/2014)... 2014 The click strand ... strength and durability. Today, the business announces a ... valid until Jan. 30, 2015. , Click strand ... hardwood. BambooFlooringChina.com is a well-known brand in the ... to find a reliable bamboo flooring supplier. , ...
(Date:12/25/2014)... 2014 Product liability lawsuits filed in ... ( http://www.consumerinjurylawyers.com/DePuy/ ) continue to move forward in federal ... issued in the U.S. District Court, Northern District of ... open conference on January 7, 2015, at the Paul ... West Palm Beach, Florida. The Conference is scheduled to ...
(Date:12/25/2014)... Recently, Dylan Queen, a famous online company supplying ... of discounted prom dresses, most of which are priced ... the company, the promotion is valid until Jan. 22, ... the UK market. , The prom dresses in this ... styles: A-line strapless, empire strapless chiffon, one shoulder, floor-length, ...
(Date:12/25/2014)... sells many bamboo products and the business is famous ... announces big discounts on its bamboo mats , which ... the world’s leader in bamboo flooring. According to the ... 2015. , The bamboo mats are made from well-treated ... the bamboo strips for the mats are boiled and ...
Breaking Medicine News(10 mins):Health News:Parker & Sons Announces Record Demand For 24 Hour Emergency Services In 2014 With Regard To Air-Conditioning Systems 2Health News:Parker & Sons Announces Record Demand For 24 Hour Emergency Services In 2014 With Regard To Air-Conditioning Systems 3Health News:BambooFlooringChina.com: click strand woven bamboo flooring promotion valid until Jan. 30, 2015. 2Health News:Federal Court Overseeing DePuy ASR Hip Lawsuit Set to Convene Conference in January, Bernstein Liebhard LLP Reports 2Health News:Federal Court Overseeing DePuy ASR Hip Lawsuit Set to Convene Conference in January, Bernstein Liebhard LLP Reports 3Health News:Dylan Queen: Cheap Prom Dresses for the UK Market 2Health News:Various Styles of Bamboo Mats in Many Colors from BambooFlooringChina.com 2
... JULY 26, 2011] Antibiotic overuse and resistance have emerged ... an outbreak of Clostridium difficile infections, which often result ... targeted physicians and pharmacists with an education campaign that ... in Clinical Infectious Diseases and now available ...
... are needed to evaluate access to care by minority ... African Americans, and to assess the benefits of new ... technology and access to multilevel diabetes education teams, according ... a peer-reviewed journal published by Mary Ann Liebert, Inc. ...
... MONDAY, July 25 (HealthDay News) -- Hospitalized patients who are ... more satisfied with their care, but one-fifth are not given ... The authors of the new study compiled information on ... a three-year period, and had the patients rate their sense ...
... HealthDay Reporter , MONDAY, July 25 (HealthDay News) -- ... the United States, a new study shows. The vaccine, ... chickenpox by 88 percent in all age groups and by 97 ... from the National Center for Immunization and Respiratory Diseases. ...
... UT Southwestern Medical Center researchers have narrowed the ... that late-stage tumors are driven by a different hormonal ... is generally known to stimulate the growth of the ... hormonal therapy actually is driven by a pathway that ...
... roads in Dunn County, North Dakota, they stir up more ... contain such high levels of the mineral erionite that those ... increased risk of developing mesothelioma, a type of cancer of ... a natural mineral fiber that shares similar physical similarities with ...
Cached Medicine News:Health News:Simple guidelines decreased unnecessary antibiotic use in Quebec, Canada 2Health News:New data-based strategies and treatment models can improve diabetes care for older African-Americans 2Health News:Spiritual Talks May Boost Patients' View of Hospital Care 2Health News:Chickenpox Vaccine May Wipe Out Related Deaths: Study 2Health News:Chickenpox Vaccine May Wipe Out Related Deaths: Study 3Health News:UT Southwestern scientists discover new pathway to potential therapies for advanced prostate cancer 2Health News:New study finds cancer-causing mineral in US road gravel 2Health News:New study finds cancer-causing mineral in US road gravel 3
(Date:12/24/2014)... Dec. 24, 2014  Novastem, a leader in ... patient in its study for ischemic stroke at ... Association, ischemic strokes account for 87 percent of ... patients in the study, entitled "Internal Research Protocol ... Mesenchymal Stem Cells and Intrathecal Administration of Neural ...
(Date:12/24/2014)... , Dec. 24, 2014  Commonwealth Cornerstone Group (CCG) today ... Credits transaction on Tuesday to help fund the expansion and ... in Sharon . PHN ... Pennsylvania . It is the largest employer in ... than 150 people on staff. Currently, PHN Sharon ...
(Date:12/24/2014)... , Dec. 24, 2014 Kinex Pharmaceuticals announced ... KX2-361 at Roswell Park Cancer Institute. KX2-361 ... drug that has shown potent inhibitory activity against a ... that are resistant to Temozolomide (T98G), the most widely ... a well-established brain tumor mouse model, KX2-361 consistently clears ...
Breaking Medicine Technology:Novastem Treats First Patient Using Stemedica's Mesenchymal and Neural Stem Cell Combination Therapy for Ischemic Stroke 2Novastem Treats First Patient Using Stemedica's Mesenchymal and Neural Stem Cell Combination Therapy for Ischemic Stroke 3Novastem Treats First Patient Using Stemedica's Mesenchymal and Neural Stem Cell Combination Therapy for Ischemic Stroke 4Commonwealth Cornerstone Group Announces $8 Million in Tax Credits to Expand and Consolidate Healthcare Services in Sharon 2Commonwealth Cornerstone Group Announces $8 Million in Tax Credits to Expand and Consolidate Healthcare Services in Sharon 3Kinex Pharmaceuticals Announces First Patient Dosed with KX2-361 in a Phase 1 Clinical Study 2Kinex Pharmaceuticals Announces First Patient Dosed with KX2-361 in a Phase 1 Clinical Study 3
... MINNEAPOLIS, Aug. 31, 2011 This evening, ... community organizations to support programs that educate people living ... their diabetes and reduce the risk of long-term diabetes ... Nordisk Community Care program, which aims to promote enduring, ...
... ALISO VIEJO, Calif., Aug. 31, 2011 Avanir Pharmaceuticals, Inc. ... will present an overview of the company at the Stifel Nicolaus ... Hotel, Boston, MA Presentation date: Wednesday September 7, 2011 ... A live webcast and 30-day archive of these presentations will ...
Cached Medicine Technology:Novo Nordisk Partners with Minneapolis Community Groups to Support Diabetes Education Programs 2
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... 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 ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... 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: