Navigation Links
Cell Therapeutics Resubmits Pixantrone NDA to FDA for Consideration of Accelerated Approval
Date:10/24/2011

SEATTLE, Oct. 25, 2011 /PRNewswire/ -- Cell Therapeutics, Inc. ("CTI") (NASDAQ and MTA: CTIC) today announced that it has resubmitted the pixantrone New Drug Application ("NDA") to the U.S. Food and Drug Administration's ("FDA") Division of Oncology Drug Products ("DODP") for accelerated approval to treat relapsed or refractory aggressive non-Hodgkin's lymphoma ("NHL") in patients who failed two or more lines of prior therapy.

CTI had appealed the FDA's Complete Response Letter for the pixantrone NDA based on the results of the PIX301 clinical trial. In May 2011, the FDA's Office of New Drugs ("OND") responded to CTI's appeal recommending that CTI conduct an additional review of radiographs utilizing a new independent panel of radiologists to confirm the response and progression events noted in the pixantrone NDA in order to determine that efficacy had been established.  CTI recently announced that a second independent radiology assessment of response and progression endpoint data confirmed the statistical robustness of the PIX301 efficacy data contained in the NDA.

In June 2011, CTI met with the DODP to review its plans for responding to the items noted in the Complete Response Letter ("CRL"), as well as its plans for addressing the items noted by the OND in response to the appeal. The Company believes the information contained within the resubmitted NDA adequately addresses the recommendations from the OND and items noted in the CRL.

"We believe the resubmitted NDA not only addresses the items in the Complete Response Letter, but confirms the reliability of the initial efficacy results, which we believe demonstrates that pixantrone does provide a clinical benefit to this patient population for which there are no currently approved therapies," said James A. Bianco, M.D., CEO of CTI.

The DODP previously confirmed that the review of the NDA would be completed within six months from the date of resubmission, which should provide C
'/>"/>

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

Page: 1 2 3 4

Related medicine technology :

1. Halozyme Therapeutics to Present Data on PEGPH20 at the Upcoming 2011 EORTC-NCI-ASCO Annual Meeting
2. Cell Therapeutics, Inc. (CTI) to Present at 10th Annual BIO Investor Forum
3. Nile Therapeutics Completes Dosing of Clinical Trial Evaluating the Subcutaneous Infusion of Cenderitide in Chronic Heart Failure Patients
4. Depression Therapeutics - Pipeline Assessment and Market Forecasts to 2018
5. Karyopharm Therapeutics Inc. and Katholieke Universiteit Leuven Sign Exclusive Collaboration for the Discovery of Novel CRM1/Exportin 1 Inhibitors
6. Echo Therapeutics Hires Product Development Management Executive
7. Prime Therapeutics Demonstrates Willingness to Show Actual Pharmacy Costs
8. Echo Therapeutics Announces Positive Results of Clinical Trial of Its Symphony® Continuous Glucose Monitoring System
9. Womens Health Therapeutics, Analysis and Market Forecasts to 2016 - High Unmet Need will Drive the Uptake of Novel Drugs in the Menopause and Osteoporosis Markets
10. Metabolic Disorders Therapeutics Market to 2017 - Patent Expiry of Lipitor in 2011 will Negatively Impact Dyslipidemia Market Value
11. Argos Therapeutics Late Scientific Co-founder Ralph Steinman, M.D., Awarded Nobel Prize in Medicine for Discovery of Dendritic Cells as Critical Sentinels of Immune System
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... and Markets ( http://www.researchandmarkets.com/research/6k27gw/dental ) has announced the addition ... Analysis, Size, Share, Growth, Trends And Forecast, 2013 - ... (Logo: http://photos.prnewswire.com/prnh/20130307/600769 ) Dental ... order to treat dental impairments, for tooth restoration and ...
(Date:1/15/2014)... , Jan. 15, 2014  Novation, the leading health care ... new IT value-added reseller (VAR) national contracts that expand ... and services at lower costs. These include manufacturer product ... as initiative assistance and ongoing IT consulting support. ...
(Date:1/15/2014)... Shire plc (LSE: SHP, NASDAQ: SHPG ) ... approval condition to the announced tender offer for all of the ... a result of the waiver, the transaction is no longer conditional ... on January 24, 2014 following the currently scheduled expiration time, subject ...
Breaking Medicine Technology:Dental Consumables Market - Global Industry Analysis, Size, Share, Growth, Trends And Forecast, 2013 - 2018 2Dental Consumables Market - Global Industry Analysis, Size, Share, Growth, Trends And Forecast, 2013 - 2018 3New Novation Information Technology VAR Contracts Offer Significant Savings to Hospitals 2Shire Waives OFT Condition Relating to the Acquisition of ViroPharma Inc. 2Shire Waives OFT Condition Relating to the Acquisition of ViroPharma Inc. 3
... MPMN and PlasticsToday.com, both leading news and ... today announced the launch of a new conference on ... the latest technological and regulatory developments in the use ... sustained growth despite broader economic difficulties, the value of ...
... N.J., Oct. 10, 2011 Cantel Medical Corp. (NYSE: ... quarter and fiscal year ended July 31, 2011 on Thursday, ... call to discuss the results at 11:00 AM ET.  Participating ... A. Krakauer, President and CEO; Seth R. Segel, Executive Vice ...
Cached Medicine Technology:MPMN and PlasticsToday Launch New Specialist Conference on Innovations in Medical Polymers 2Cantel Medical Corp. to Hold Conference Call to Discuss Fourth Quarter and Fiscal 2011 Results 2
(Date:4/24/2014)... corresponding terminology, and the relevance of palliation in ... on randomized controlled trials (RCTs). This is the ... for Quality and Efficiency in Health Care (IQWiG), ... , Together with external experts, IQWiG analysed studies ... cancer, malignant melanoma, and pancreatic cancer. For this ...
(Date:4/24/2014)... has been awarded one of 30 grants from the ... Academic Participating Site in its new National Clinical ... select groups of investigators charged with distributing resources in ... NCTN grant system reflects recommendations from a 2010 ... achieve four goals:, Faster design, launch, and ...
(Date:4/23/2014)... Hospital (MGH) investigators may lead to greater availability and ... problem use of fecal material from healthy donors ... difficile ( C. difficile ) bacteria. In ... Clinical Infectious Diseases , the researchers report that use ... patients was as successful in curing recurrent C. ...
(Date:4/23/2014)... National Institute of Arthritis and Musculoskeletal and Skin Diseases ... Ross Prize in Molecular Medicine, conferred by the Feinstein ... award will be given on June 9 at the ... scientific presentations by Dr. O,Shea and other prominent researchers. ... , The award, which includes a $50,000 prize from ...
(Date:4/23/2014)... pathway that helps prevent new cells from receiving too ... been directly linked to cancer and other diseases. , ... the end of cell division, the enzyme Cdc14 activates ... are fully repaired before the parent cell distributes copies ... safeguard against some of the most devastating genome errors, ...
Breaking Medicine News(10 mins):Health News:Palliation is rarely a topic in studies on advanced cancer 2Health News:Palliation is rarely a topic in studies on advanced cancer 3Health News:Dartmouth awarded lead role in NCI clinical trials network 2Health News:Dartmouth awarded lead role in NCI clinical trials network 3Health News:Use of frozen material for fecal transplant successfully treats C. difficile infection 2Health News:Use of frozen material for fecal transplant successfully treats C. difficile infection 3Health News:NIH scientist to receive Ross Prize in Molecular Medicine 2Health News:Study identifies enzymes that help fix cancer-causing DNA defects 2
... Older African American women who have experienced high levels ... to suffer worse physical and mental health than their ... of the Journal of Women,s Health . , ... health issues such as depression and anxiety, and more ...
... Following a review by The Lancet of the ... of Cardiology has reaffirmed its advice about the risks of ... , is increased "up to four-fold" by long-haul flight. , ... flying is associated with an increase in deep venous thrombosis, ...
... flights in 9 minutes, 31 secondsCHICAGO, Feb. 23 Over ... Hancock stair climb event on Sunday, February 22. They did ... lung disease, the third leading cause of death and disability ... raise more than $1 million to benefit Respiratory Health Association ...
... VANCOUVER, Feb. 24 /PRNewswire-FirstCall/ - CRH Medical Corporation announced ... Hemorrhoid banding technology has been adopted by more than ... Company since June 2008. The Company believes this provides ... but also confirmation of the consistency of its training ...
... new survey from global market research firm Synovate shows that less than ... months. Of those, only 10% received it at a pharmacy and just ... ... February 24, 2009 -- According to a new survey by leading market ...
... Online-Only Event Brings Together Leading Cardiovascular ExpertsLAS ... Inc. (NMT), an award-winning company engaged in ... today announced that the Company will be ... medical assessment and communications products at CardioCareLive, ...
Cached Medicine News:Health News:Triple threat to health 2Health News:ESC reaffirms advice on cardiovascular risks associated with long-haul flights 2Health News:Over 4,000 Hustle Up the Hancock to Fight Lung Disease 2Health News:CRH provides Partnership Program update 2Health News:New survey: Flu Shot Still not Catching on, Especially at Retail Clinics 2Health News:Noninvasive Medical Technologies to Exhibit at CardioCareLive - A Premier Cardiometabolic Conference 2Health News:Noninvasive Medical Technologies to Exhibit at CardioCareLive - A Premier Cardiometabolic Conference 3
... Mesh Self-Forming Plug is a mesh plug ... well as primary inguinal hernias and femoralhernias. ... defect and fills it completely. Premilene Mesh ... of the established Premilene Mesh. The plug ...
... The Celsius Control System provides ... can safely,and rapidly lower patient ... target temperature and,rewarm patients to ... System consists of an endovascular,catheter, ...
... , it maximizes use by allowing ... it, while the third lamp is ... care in mind, it includes universal ... An excellent choice for hospital operating ...
... Perfectly balanced, the patented Orion incorporates ... that illuminates brilliantly. The fully adjustable ... designed to sit low on the brow, ... vision. Two clips on the headband ...
Medicine Products: