Navigation Links
European Regulatory Agency Accepts Cell Therapeutics, Inc.'s Marketing Authorization Application for XYOTAX(TM) for Lung Cancer for Review
Date:4/1/2008

SEATTLE, April 2, 2008 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; MTA) today announced that the European Medicines Agency (EMEA) has accepted for review CTI's Marketing Authorization Application (MAA) for XYOTAX(TM) (paclitaxel poliglumex, CT-2103) for first-line treatment of patients with non-small cell lung cancer (NSCLC) with ECOG (Eastern Cooperative Oncology Group) performance status 2 (PS2). CTI submitted the MAA at the beginning of March. The validation of the MAA for XYOTAX initiates the marketing approval review process, which generally takes 15 to 18 months. The application is based on advice from the Scientific Advice Working Party, or SAWP, at the EMEA. The EMEA agreed that switching the primary endpoint from superiority to non-inferiority is feasible if the retrospective justification provided in the marketing application is adequate. The discussions with the SAWP focused on using the STELLAR 4 study as primary evidence of non-inferiority and the STELLAR 3 study as supportive of the MAA.

In the STELLAR 4 trial, single-agent XYOTAX resulted in comparable survival to gemcitabine or vinorelbine in first-line patients and, with the exception of neuropathy known to be associated with taxane therapy, demonstrated significant reduction in several clinically meaningful toxicities, such as severe neutropenia and infection, and in the requirement for transfusions and use of hematopoietic growth factor support. In addition to improved tolerability, XYOTAX offered more convenient administration compared to currently used treatments and a reduction in overall utilization of medical resources compared to gemcitabine or vinorelbine.

"CTI looks forward to working with the EMEA as it begins the review
'/>"/>

SOURCE Cell Therapeutics, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. CV Therapeutics Announces Eight Abstracts Accepted for Presentation at the European Society of Cardiology Congress 2007
2. Boston Scientific Announces Schedule for European Society of Cardiology Congress 2007
3. European Experts Recommend Pregnant and Nursing Women Take More DHA - Every Day
4. Genasense(R) Data in Melanoma to be Presented in Opening Session at First Worldwide Melanoma Center Meeting of the European Association of Dermato-Oncology
5. Terumo Heart to Announce Results of European Clinical Trial of DuraHeart(TM) LVAS at European Association of Cardiothoracic Surgeons Meeting in September
6. Threshold Pharmaceuticals Announces Two Presentations on Glufosfamide at the 2007 European Cancer Conference (ECCO)
7. Study Results for Aclidinium Bromide, a Novel Anticholinergic, Presented at European Respiratory Society Annual Congress
8. Life Recovery Systems Receives European CE Mark Approval for Its ThermoSuit(R) System
9. Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell Lung Cancer
10. European Unions CHMP Issues Positive Opinion on PEGINTRON(TM) Combination Therapy for Retreating Hepatitis C Patients Who Failed Previous Therapy
11. Positive Xeloda(R) Five-Year Overall Survival Study Data in the Adjuvant Treatment of Colon Cancer Presented at Leading European Cancer Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/17/2014)... WHIPPANY, N.J. , Sept. 17, 2014  Bayer ... the National Hemophilia Foundation,s 66 th Annual Meeting, ... , D.C.  The data, which will be shared ... A treatment and patient care. Data will be presented ... display research into treatment modalities in hemophilia A patients, ...
(Date:9/17/2014)... COLUMBUS, Ohio , Sept. 17, 2014 /PRNewswire/ ... Riverside Radiology and Interventional Associates announced today ... Systems to enhance its image sharing capabilities ... case of any network failures. In addition, the ... to help navigate disparate PACS systems to more ...
(Date:9/17/2014)... , Sept. 17, 2014   myMatrixx, a pharmacy and ... that Business Insurance magazine has awarded myMatrixx ... for the third year in a row. ... of Business Insurance  and the Best Companies Group. ... open to all publicly or privately-held insurance industry companies ...
Breaking Medicine Technology:Bayer to Present Data on Hemophilia Research at NHF in Washington, D.C. 2Bayer to Present Data on Hemophilia Research at NHF in Washington, D.C. 3Bayer to Present Data on Hemophilia Research at NHF in Washington, D.C. 4Dicom Systems' Innovative Software Provides Enhanced Imaging Sharing Capabilities, as Well as Connection Reliability in the Case of Network Failure 2Dicom Systems' Innovative Software Provides Enhanced Imaging Sharing Capabilities, as Well as Connection Reliability in the Case of Network Failure 3myMatrixx Honored with "Best Places to Work in Insurance" Award 2
... - Positive data on subcutaneous administration show potential ... CHICAGO, June 04, 2007 /PRNewswire-FirstCall/ -- Millennium,Pharmaceuticals, Inc. ... the market-leading therapy for patients with,multiple myeloma (MM) ... data include results from a Phase II trial ...
... CHICAGO, June 04, 2007 /PRNewswire/ -- GlaxoSmithKline ... of pazopanib in,advanced or metastatic renal cell ... (STS). These trials were presented at the,43rd ... Clinical Oncology,(ASCO) in Chicago. The results observed ...
Cached Medicine Technology:New Data on Market-Leading Velcade (Bortezomib) for Injection,Further Strengthen Role in Previously Treated Multiple Myeloma 2New Data on Market-Leading Velcade (Bortezomib) for Injection,Further Strengthen Role in Previously Treated Multiple Myeloma 3New Data on Market-Leading Velcade (Bortezomib) for Injection,Further Strengthen Role in Previously Treated Multiple Myeloma 4New Data on Market-Leading Velcade (Bortezomib) for Injection,Further Strengthen Role in Previously Treated Multiple Myeloma 5New Data on Market-Leading Velcade (Bortezomib) for Injection,Further Strengthen Role in Previously Treated Multiple Myeloma 6New Data on Market-Leading Velcade (Bortezomib) for Injection,Further Strengthen Role in Previously Treated Multiple Myeloma 7GSK'S Pazopanib Shows Positive Results in Patients with Advanced,Renal Cell Carcinoma, Ovarian Cancer and Soft Tissue Sarcoma 2GSK'S Pazopanib Shows Positive Results in Patients with Advanced,Renal Cell Carcinoma, Ovarian Cancer and Soft Tissue Sarcoma 3GSK'S Pazopanib Shows Positive Results in Patients with Advanced,Renal Cell Carcinoma, Ovarian Cancer and Soft Tissue Sarcoma 4GSK'S Pazopanib Shows Positive Results in Patients with Advanced,Renal Cell Carcinoma, Ovarian Cancer and Soft Tissue Sarcoma 5GSK'S Pazopanib Shows Positive Results in Patients with Advanced,Renal Cell Carcinoma, Ovarian Cancer and Soft Tissue Sarcoma 6GSK'S Pazopanib Shows Positive Results in Patients with Advanced,Renal Cell Carcinoma, Ovarian Cancer and Soft Tissue Sarcoma 7
(Date:9/17/2014)... 2014 In Pretrial Order #139 (Scheduling ... discovery conferences would be beneficial in this [MDL].” Accordingly, ... “At the end of December,” the order further provides, ... additional conferences. , “The plain import of this ... still much to be discussed as these cases progress ...
(Date:9/17/2014)... Dennis Thompson HealthDay ... -- Exposure in the womb to household chemicals known ... developing asthma, Columbia University researchers reported in a new ... risk of developing asthma between age 5 and 11 ... levels of two phthalates (pronounced thal-ates), the researchers found. ...
(Date:9/17/2014)... Scripps Research Institute (TSRI) have devised a new ... against vancomycin-resistant strains of MRSA and other disease-causing ... have not one but two distinct mechanisms of ... resistance quickly. , "This is the prototype of ... clinical use a generation or maybe even two ...
(Date:9/17/2014)... York, New York (PRWEB) September 17, 2014 ... filings involving the Conserve line of metal-on-metal hip ... now underway in U.S. District Court, Northern District ... an updated Case List issued by the U.S. ... 2014, at least 397 product liability claims have ...
(Date:9/17/2014)... Toledo, Ohio (PRWEB) September 17, 2014 ... hearing for today, September 17, 2014, to consider: , ... Testosterone Replacement Therapy (TRT), and, 2. ... of TRT. , With the TRT litigation ongoing, an ... FDA on the dangers of testosterone replacement therapy. Among ...
Breaking Medicine News(10 mins):Health News:Transvaginal Mesh Lawsuit News: New Order in C.R. Bard MDL Sets Schedule of Conferences for September to December, the Rottenstein Law Group LLP Reports 2Health News:Prenatal Exposure to Chemicals in Plastics Linked to Asthma Risk in Kids 2Health News:Prenatal Exposure to Chemicals in Plastics Linked to Asthma Risk in Kids 3Health News:Prenatal Exposure to Chemicals in Plastics Linked to Asthma Risk in Kids 4Health News:Scripps Research Institute chemists modify antibiotic to vanquish resistant bacteria 2Health News:Scripps Research Institute chemists modify antibiotic to vanquish resistant bacteria 3Health News:Wright Hip Lawsuit News: Nearly 400 Filings Reported in Federal Wright Conserve Hip Replacement Litigation, Bernstein Liebhard LLP Reports 2Health News:Wright Hip Lawsuit News: Nearly 400 Filings Reported in Federal Wright Conserve Hip Replacement Litigation, Bernstein Liebhard LLP Reports 3Health News:FDA Advisory Committee Holds Hearing on Testosterone Safety 2
... From June Dairy Month through,the State Fair, summer ... June 1, Minnesotans will be able get details about ... mouse. ExploreDairy.com is a,one-stop resource for all the latest ... hardworking dairy farm families., ExploreDairy.com is designed to ...
... 29 The following is a,statement by Matthew L. ... Health Organization,s World No Tobacco Day, to be celebrated,May ... of the global,tobacco epidemic and the urgent need for ... save lives., This year,s theme -- Tobacco-Free Youth: ...
... May 29 The Academy of General,Dentistry (AGD) expresses ... reauthorize the Dental Health Improvement Act (S,3067) for another ... and Benjamin Cardin (D-MD). The intent of the Act ... shortage of dental health,professionals., "Last week was a ...
... Leaders of Indiana and Purdue universities Thursday ... Translational Sciences Institute (CTSI), a medical research initiative ... business and government to swiftly transform discoveries into ... National Institutes of Health has awarded a five-year ...
... The Musculoskeletal Transplant,Foundation (MTF) will provide military hospitals ... joint repair for injured servicemen and,women., Military ... obtaining,tissue used for cartilage transplantation and meniscus grafts ... types of tissue are in high,demand for U.S. ...
... NY) The National Institutes of Health has ... University and Montefiore Medical Center one of its ... million over five years. The grant will support ... Research (ICTR), whose overarching goal is to collaboratively ...
Cached Medicine News:Health News:ExploreDairy.com Debuts With Information on Minnesota Dairy Events, People and Products 2Health News:World No Tobacco Day Sounds Urgent Call for Nations to Fight Tobacco Use, Save Lives 2Health News:World No Tobacco Day Sounds Urgent Call for Nations to Fight Tobacco Use, Save Lives 3Health News:AGD Thanks Senators for Introducing Bill to Reauthorize the Dental Health Improvement Act 2Health News:NIH awards Einstein College of Medicine & Montefiore Medical Center $22M grant 2Health News:NIH awards Einstein College of Medicine & Montefiore Medical Center $22M grant 3
... High Prevalence of Sleep Disordered Breathing (SDB) ... As Prevalent as Diabetes, with Vast Majority ... common form of SDB, affects an estimated ... Only 5% of the OSA patients ...
... The layout is designed efficiently for ... are configured for maximum efficiency. It ... It can be set-up in ... any mobile modality pad and it ...
... PowerSuite holmium laser combines excellent cutting, ... virtually bloodless procedures. It is also ... gall bladder stones of all compositions, ... tool. Because its laser light is ...
... holmium laser combines excellent cutting, ablation ... bloodless procedures. It is also extremely ... bladder stones of all compositions, making ... Because its laser light is transmitted ...
Medicine Products: