Navigation Links
FDA Sets April 24, 2012 as PDUFA Goal Date for Cell Therapeutics' Resubmitted Pixantrone New Drug Application
Date:12/6/2011

SEATTLE, Dec. 6, 2011 /PRNewswire/ -- Cell Therapeutics, Inc. ("CTI") (NASDAQ and MTA: CTIC) today announced that the U.S. Food and Drug Administration's ("FDA") Division of Oncology Products 1 ("DOP1") has notified CTI that CTI's October 2011 resubmitted New Drug Application ("NDA") is considered a complete, Class 2 response to the FDA's April 2010 complete response letter ("CRL"). The FDA has set a Prescription Drug User Fee Act ("PDUFA") goal date of April 24, 2012 for a decision on the NDA.   The NDA seeks accelerated approval of pixantrone to treat relapsed or refractory aggressive non-Hodgkin's lymphoma ("NHL") in patients who failed two or more lines of prior therapy.

Pixantrone is also under review for marketing approval in Europe with a Committee for Human Medicinal Products ("CHMP") opinion on the application tentatively scheduled on January 19, 2012.

"We look forward to working with the FDA and the European Medicines Agency ("EMA") to bring this drug to patients for whom there are currently no approved therapies," James A. Bianco, M.D. Chief Executive Officer stated.

CTI appealed the CRL for the pixantrone NDA based on the results of the PIX301 clinical trial. The FDA's Office of New Drugs ("OND") responded to CTI's appeal by providing CTI with an opportunity to resubmit the NDA with additional information, but without conducting an additional clinical trial. In June 2011, CTI met with the DOP1 to review CTI's plans for responding to the items noted in the CRL including CTI's plans for addressing the items noted by the OND in response to the appeal.

About Pixantrone

Pixantrone is a novel aza-anthracenedione that has distinct structural and physio-chemical properties that make its anti-tumor activity unique in this class of agents. Similar to anthracyclines, pixantrone inhibits Topo-isomerase II but unlike anthracyclines -- rather than intercalation with DNA -- pixantrone alkylates DNA -- forming sta
'/>"/>

SOURCE Cell Therapeutics, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Alseres Pharmaceuticals, Inc. to Address a Congressional Briefing on Paralysis Research and the Spinal Cord Injury Community at Working 2 Walk in Washington, DC, April 13-15, 2008
2. ViroPharma to Release 2008 First Quarter Financial Results on April 30, 2008
3. April 16th Congressional Hearing on Hospital Infections
4. The COSHAR Foundation Launches National Childhood Immunization Awareness Campaign During National Infant Immunization Week (April 19-26)
5. PharmAthene to Host a Conference Call and Webcast on Wednesday, April 29th at 4:30 PM to Provide an Update on the SparVax(TM) rPA Anthrax Vaccine Program
6. FDA Sets Action Date of April 23, 2010 for Review of Pixantrone NDA
7. 2nd Annual Orthopedic Design & Technology Forum Returns April 28 to the FedEx Institute of Technology, University of Memphis
8. Stryker to Host Conference Call on April 20, 2010
9. FDA Consumer Health Information - Generic Drug Roundup: April 2010
10. United Therapeutics Corporation To Announce First Quarter 2010 Financial Results Before Market Open on Thursday, April 29, 2010
11. CardioGenics to be Spotlighted in Three Publications During Month of April
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/25/2014)... 2014 /PRNewswire-iReach/ -- "Australia Capsule Endoscopy Systems Market Outlook ... Capsule Endoscopy Systems market. The report provides value, in ... prices (in US dollars) within market segments: ... Capsule Endoscopes , Capsule Endoscopy Data Recorders ... also provides company shares and distribution shares data for ...
(Date:7/25/2014)... , July 25, 2014 /PRNewswire-iReach/ -- ScriptPro, ... TCGRx, of Powers Lake, Wisconsin ... in a distribution and co-marketing agreement allowing ScriptPro ... pharmacies throughout the United States ... pharmacy management and workflow systems to retail and ...
(Date:7/25/2014)... , July 25, 2014 GrowBLOX Sciences, Inc. (OTCQB: ... Memorandum of Understanding ("MOU") with LaurelCo, LLC, an ... acquisition of both cultivation and dispensary medical marijuana licenses in ... the MOU, GBLX will acquire a 20% equity interest in ... GrowBLOX TM growing chambers, as well as all technology ...
Breaking Medicine Technology:Australia Capsule Endoscopy Systems Market Analysis and Forecast to 2020 2Australia Capsule Endoscopy Systems Market Analysis and Forecast to 2020 3Australia Capsule Endoscopy Systems Market Analysis and Forecast to 2020 4Australia Capsule Endoscopy Systems Market Analysis and Forecast to 2020 5ScriptPro and TCGRx Integrate Pharmacy Automation Technologies 2ScriptPro and TCGRx Integrate Pharmacy Automation Technologies 3GrowBLOX Sciences, Inc. Partners with LaurelCo, LLC to Obtain Licenses to Cultivate and Dispense Medical Marijuana in Illinois 2GrowBLOX Sciences, Inc. Partners with LaurelCo, LLC to Obtain Licenses to Cultivate and Dispense Medical Marijuana in Illinois 3
... YORK, Feb. 28, 2012  On February 28th, 2012, the ... for those interested in speaking at its 2012 Digital ... New York City,s Pier Sixty. At ... in New York City—over 600 healthcare providers, healthcare technology ...
... Feb. 28, 2012   Alexander Orthopaedic Associates (AOA) in ... in their practice with White Plume Technologies between ... Systems, (ADSC) practice management system (PM system). ... gaps in the billing process unfilled. White Plume Technologies ...
Cached Medicine Technology:Call for Speakers: New York's Digital Health Conference 2012 2Alexander Orthopaedic Associates Chooses White Plume Technologies to Fill the EMR Gap 2
(Date:7/26/2014)... WA (PRWEB) July 26, 2014 According ... by Vkool.com, this is a comprehensive guide that covers ... (KP) effectively without the need of any medication. ... book consists of natural and safe remedies for relieving ... book, people will learn:,     How to ...
(Date:7/26/2014)... The birth control safety center at DrugNews.net ... new legal information on the site. A federal panel ... lawsuits pending for July alleging side effects from the ... using popular prescription drugs and medical devices. By giving ... news all in one place, they can see if ...
(Date:7/25/2014)... 2014 Deep Research Report ... Industry” is a professional and in-depth research ... Permeation Chromatography market. The report provides basic ... Chromatography definition, classification, application, and industry chain ... research covers the international market analysis, including ...
(Date:7/25/2014)... According to a new market ... (vibration monitoring, thermography, ultrasound emission, lubricating oil analysis, ... and Geography - Global Forecast to 2014 - ... market is expected to reach $2.50 at a ... Browse 117 market data Tables and 57 Figures ...
(Date:7/25/2014)... As reported by the Statesman Journal in the article ... in Salem, MA as well as several other states are ... that has taken many lives during the past couple of ... which police were able to make two arrests by following ... be the victim and claiming to want to buy more ...
Breaking Medicine News(10 mins):Health News:Banish My Bumps Pdf Review Exposes Angela Steinberg's Keratosis Pilaris Treatment Plan – Vkool.com 2Health News:Banish My Bumps Pdf Review Exposes Angela Steinberg's Keratosis Pilaris Treatment Plan – Vkool.com 3Health News:DrugNews Adds Latest Court Updates on Mirena IUD Lawsuits 2Health News:2014 China & Global GPC Industry - Gel Permeation Chromatography Development Trends Now at DeepResearchReports.com 2Health News:2014 China & Global GPC Industry - Gel Permeation Chromatography Development Trends Now at DeepResearchReports.com 3Health News:Machine Health Monitoring Market by Product, Component & Application Worth $2.50 Billion by 2020 - New Report by MarketsandMarkets 2Health News:Machine Health Monitoring Market by Product, Component & Application Worth $2.50 Billion by 2020 - New Report by MarketsandMarkets 3Health News:Machine Health Monitoring Market by Product, Component & Application Worth $2.50 Billion by 2020 - New Report by MarketsandMarkets 4Health News:Multiple States Crack Down on Heroin Epidemic 2
... in the July issue of Archives of Surgery,the rate ... bacteria Clostridium difficile more than doubled among patients ... and the illness was more severe and associated with ... intestines of approximately 1 percent to 3 percent of ...
... of Delaware scientists has revealed that non-contact knee injuries ... ,At UD's Human Performance Lab, researchers are ... and react to unanticipated events. ,To identify ... to nearly 1,500 athletes at 18 universities during the ...
... tonsillectomy, or removal of the tonsils, none reported an ... procedure . ,Together with the sense of ... of taste contributes considerably to flavor perception during eating ... the enjoyment of foods and beverages, according to background ...
... gender barriers to careers in medical research and teaching, ... the year-long Women in Academic Medicine study* are published ... that: ,,Women doctors are strikingly under-represented in ... out of all 33 heads of UK medical schools ...
... captive audience for smoking cessation efforts, according to a new ... smokers become hospital inpatients, regardless of the reason for admission, ... smoking after discharge and more likely succeed in the long ... a persons health, but many of them dont really believe ...
... children are found cherishing coca cola drinks at home or ... ,Sajid sneaks into courtyards and garages around ... is a big headache for his neighbours. ,His ... just two-and-a-half years of age. It was while playing outside ...
Cached Medicine News:Health News:Colitis More Common in Hospitalized Patients 2Health News:Colitis More Common in Hospitalized Patients 3Health News:Colitis More Common in Hospitalized Patients 4Health News:Differences in Brain Functions Results in non-contact Knee Injuries 2Health News:Differences in Brain Functions Results in non-contact Knee Injuries 3Health News:Patients Undergoing Tonsillectomy Shows No Change of Taste 2Health News:Female Doctors Facing Barriers to Careers in Education and Research, Study Finds 2Health News:Smokers may Be Motivated to Quit During Interventions in Hospital Stays 2Health News:Smokers may Be Motivated to Quit During Interventions in Hospital Stays 3Health News:Meet the petroholic Boy of Kanpur 2
... is a sterile, pre-shaped, three-dimensional device constructed ... mesh cylinder to a circular underlay patch.,The ... and innovative design combines the three most ... the repair of inguinal hernias. ,Its Onlay ...
Surgisis Inguinal Hernia Matrix is implanted to reinforce soft tissues in the inguinal floor to repair inguinal hernias. Supplied sterile in peel-open packages. Intended for one-time use....
... Gemini is the newest addition to Laserscopes ... distinct wavelengths to choose from, 1064nm Nd:YAG ... in an exploding non-invasive aesthetic laser market ... and effectiveness while maintaining the safety and ...
... of 532 nm lasers are distinguished from ... solid-state design. A compact and sealed ... and reliable for a broad range of ... hemoglobin and an adjustable pulse length, the ...
Medicine Products: