Navigation Links
Cell Therapeutics Announces FDA's Oncologic Drugs Advisory Committee to Review Pixantrone for the Treatment of Relapsed/Refractory Aggressive Non-Hodgkin's Lymphoma, February 10, 2010
Date:12/16/2009

SEATTLE, Dec. 17 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced today that on February 10, 2010 the U.S. Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC) will review the New Drug Application (NDA) for pixantrone for the treatment of relapsed/refractory aggressive non-Hodgkin's lymphoma (NHL). ODAC is an independent panel of experts that evaluates data concerning the efficacy and safety of marketed and investigational products for use in the treatment of cancer and makes appropriate recommendations to the FDA. The FDA regulations indicate that although the FDA will consider the recommendation of the panel, the final decision regarding the approval of the product is made by the FDA.

"The upcoming ODAC meeting is a very important milestone in the NDA review process and we look forward to discussing the efficacy and safety data for pixantrone with the members of the panel and the FDA review team," stated James A. Bianco, M.D., CEO of CTI. "As there are no other drugs currently approved in this setting, we believe that pixantrone would fulfill a significant unmet medical need for patients with relapsed/refractory aggressive NHL."

At the ODAC meeting, committee members evaluate presentations of efficacy and safety data made by the pharmaceutical sponsor of the drug under review, FDA review staff, and occasionally third-party oncology experts in an open forum. Following the presentation, the committee members discuss questions posed by the Agency review staff and the meeting concludes with the committee voting on a recommendation to the FDA regarding approval.

Pixantrone is a fast track designated product which has been accepted for review by the U.S. Food & Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) date of April 23, 2010.

About Pixantrone

Pixantrone (BBR 2778), is a novel topoisomera
'/>"/>

SOURCE Cell Therapeutics, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Vicus Therapeutics to Present at the 234th American Chemical Society National Meeting in Boston, MA
2. Allos Therapeutics Initiates Study of PDX in Patients with Cutaneous T-Cell Lymphoma
3. Amicus Therapeutics Announces Second Quarter 2007 Financial Results
4. TorreyPines Therapeutics Completes Patient Enrollment in Phase IIb Clinical Trial of Tezampanel for the Treatment of Acute Migraine Headache
5. CV Therapeutics Announces Eight Abstracts Accepted for Presentation at the European Society of Cardiology Congress 2007
6. Pharmacopeia Assists the World Health Organization in the Discovery of Novel Therapeutics for the Treatment of Malaria
7. Protalix BioTherapeutics Treats First Patient in Phase III Clinical Trial of prGCD
8. TorreyPines Therapeutics Initiates a Phase I Multiple Dose Clinical Trial of Tezampanel
9. TorreyPines Therapeutics Completes Phase I Multiple Dose Clinical Trial of NGX267, a Selective M1 Agonist for the Potential Treatment of Cognitive Impairment Associated with Schizophrenia
10. Cell Therapeutics, Inc. (CTI) Launches Phase III Study for Pixantrone in Relapsed Indolent Non-Hodgkins Lymphoma (NHL)
11. Cell Therapeutics, Inc. (CTI) Sponsors Panel Discussion on Women and Lung Cancer on Capitol Hill
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/24/2014)... Company (NYSE: PRGO ; TASE) today announced ... from the U.S. Food and Drug Administration (FDA) for ... gel 1.0%. FDA concluded that Perrigo,s testosterone product is ... substituted with the full expectation that it will produce ... 1% when used under the conditions specified in the ...
(Date:7/24/2014)... , July 24, 2014 Research ... "Machine Health Monitoring Market by Product, Component, Application and ... report to their offering. ... market is expected to witness a moderate growth as ... have almost reached the saturation levels. The ...
(Date:7/24/2014)... , July 24, 2014 /PRNewswire-iReach/ -- Delivery ... once order is placed. Photo - ... a professional and in-depth market survey on Global ... reviews the basic information of Hemodialysis Machine including ... then explores global and China,s top manufacturers of ...
Breaking Medicine Technology:Perrigo Confirms AB Therapeutic Equivalent Rating From The FDA For Its Testosterone Gel 1.0% 2Perrigo Confirms AB Therapeutic Equivalent Rating From The FDA For Its Testosterone Gel 1.0% 3Machine Health Monitoring (Vibration Monitoring, Thermography, Ultrasound Emission, Lubricating Oil Analysis, Corrosion Monitoring, Motor Current Signature Analysis) Market - Forecast to 2020 2Hemodialysis Machine Industry for Global and Chinese Markets Forecast to 2019 2Hemodialysis Machine Industry for Global and Chinese Markets Forecast to 2019 3Hemodialysis Machine Industry for Global and Chinese Markets Forecast to 2019 4Hemodialysis Machine Industry for Global and Chinese Markets Forecast to 2019 5
... Dec. 8, 2010 Reportlinker.com announces that a ... catalogue: Astellas Pharma Inc.: PharmaVitae ... IntroductionThis analysis examines the historical ... pharmaceutical sector. The profile encompasses global company strategy, ...
... 8, 2010 Healthpoint today announced that the U.S. ... commercial supplies of Collagenase SANTYL® Ointment, a biologic enzymatic ... Sterile & Specialty Products facility in Lakewood, New Jersey. ... the brand. "The approval of this second ...
Cached Medicine Technology:Reportlinker Adds Astellas Pharma Inc.: PharmaVitae Profile 2FDA Approves New Manufacturing Facility for Collagenase SANTYL® Ointment 2
(Date:7/24/2014)... Doheny HealthDay Reporter THURSDAY, ... often don,t view their kids as unhealthy or recognize the ... new study. The children of the families surveyed for ... Hasbro Children,s Hospital in Providence, R.I. "A third categorized ... researcher Dr. Kyung Rhee, now an assistant professor of pediatrics ...
(Date:7/24/2014)... have found a way to delay or even prevent ... with the anti-aging protein Klotho can prevent neuron death ... glutamate. These findings currently appear in the Journal ... the most frequent age-related dementia affecting 5.4 million Americans ... and more than 40 percent of people over the ...
(Date:7/24/2014)... (PRWEB) July 24, 2014 News ... that it has achieved certification for compliance with ... and verified by the DoD Information Assurance Certification ... Neutral Archive, identified within the DoD as the ... to Operate designation from the U.S. Army Medical ...
(Date:7/24/2014)... positive outcomes experience paradoxical feelings of pleasure and ... of the brain, according to research led by ... Princeton Neuroscience Institute at Princeton University. , ... of more than 300 products using an auction-like ... products with different or similar values and were ...
(Date:7/24/2014)... 24, 2014 Horizon BCBSNJ’s second annual ... lucky family a rent-free week in a beautiful Lavallette ... 2014. Don’t miss your chance to win a week’s ... to all New Jersey residents, 25 or older.* Residents ... http://www.facebook.com/HorizonBCBSNJ . , “A family vacation at ...
Breaking Medicine News(10 mins):Health News:Parents of Obese Kids Often View Them as Healthy 2Health News:Parents of Obese Kids Often View Them as Healthy 3Health News:BU researchers discover that Klotho is neuroprotective against Alzheimer's disease 2Health News:Perceptive Software Achieves DIACAP Certification for Vendor Neutral Archive Solution to Support U.S. Department of Defense Integrated Clinical Systems Program 2Health News:Perceptive Software Achieves DIACAP Certification for Vendor Neutral Archive Solution to Support U.S. Department of Defense Integrated Clinical Systems Program 3Health News:Perceptive Software Achieves DIACAP Certification for Vendor Neutral Archive Solution to Support U.S. Department of Defense Integrated Clinical Systems Program 4Health News:Brain's dynamic duel underlies win-win choices 2Health News:Brain's dynamic duel underlies win-win choices 3Health News:(Beach) Sands of Time Running out to Enter Horizon Blue Cross Blue Shield of New Jersey’s 2014 “Back to the Boardwalk” Sweepstakes 2
... LDG ) today reported preliminary total retail drug,store sales for the five-week and nine-week periods ended April 3, 2008., , ... Periods ended April 3, 2008, ... Month Quarter to Date (Dollars in millions) ... (9 weeks), Total retail drug store sales $474 ...
... IRIDEX,Corporation (Nasdaq: IRIX ) today reported final financial results ... Revenue for the fourth quarter of 2007 was $14.1 ... fourth quarter of 2006. The,Company,s net loss was $15.8 million ... compared with a loss of $3.8 million or $0.48 per,diluted ...
... consequences of misuse , , THURSDAY, April 10 (HealthDay News) ... abuse of powerful narcotic painkillers such as Oxycontin or ... testing --- before dispensing the medications to patients, new ... medical staff were also part of the procedures used ...
... Pennsylvania School of Medicine have discovered that a protein ... heart muscle protein called actin. Whats more, Lmod directs ... of the heart. The findings appear in this weeks ... Lmod when we began this study, says lead author ...
... Methodist Healthcare -- Memphis,Hospitals ("Methodist") announced today that it ... maturities of the,Bonds. The tender offer was extended on ... 9, 2008 at 5:00 pm, New York City time. ... terminated is applicable to,the following: for the Series 1985C ...
... Held on Saturday, April 12th at the ... Helen Mills Theatre in NYC, NEW ... performing a benefit concert on Saturday,April 12th at the Helen Mills Theatre ... This One,s Personal: A,Concert to Stop ACD," is being hosted by the ...
Cached Medicine News:Health News:Longs Reports Preliminary March Retail Drug Store Sales 2Health News:IRIDEX Reports Fourth Quarter and Full Year 2007 Financial Results 2Health News:IRIDEX Reports Fourth Quarter and Full Year 2007 Financial Results 3Health News:IRIDEX Reports Fourth Quarter and Full Year 2007 Financial Results 4Health News:IRIDEX Reports Fourth Quarter and Full Year 2007 Financial Results 5Health News:IRIDEX Reports Fourth Quarter and Full Year 2007 Financial Results 6Health News:IRIDEX Reports Fourth Quarter and Full Year 2007 Financial Results 7Health News:IRIDEX Reports Fourth Quarter and Full Year 2007 Financial Results 8Health News:User Registry May Help Docs Stem Painkiller Abuse 2Health News:Penn researchers discover 'modus operandi' of heart muscle protein 2Health News:Methodist Healthcare - Memphis Hospitals Announces Termination of Tender Offers 2Health News:Kristin Chenoweth to Perform Benefit Concert for 3 Angels Memorial Fund titled, 'Kristin Chenoweth, This One's Personal: A Concert to Stop ACD' 2Health News:Kristin Chenoweth to Perform Benefit Concert for 3 Angels Memorial Fund titled, 'Kristin Chenoweth, This One's Personal: A Concert to Stop ACD' 3
... 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 ...
... 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 ...
... 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 ...
... 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 ...
Medicine Products: