Navigation Links
Cell Therapeutics Files Appeal on FDA Decision on New Drug Application (NDA) for Pixantrone to Treat Relapsed/Refractory Aggressive Non-Hodgkin's Lymphoma
Date:12/3/2010

SEATTLE, Dec. 3, 2010 /PRNewswire/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) today announced that it has submitted a formal appeal to the Office of New Drugs in the U.S. Food and Drug Administration's Center for Drug Evaluation and Research regarding the agency's decision from earlier this year on the pixantrone New Drug Application ("NDA") to treat relapsed/refractory aggressive non-Hodgkin's lymphoma ("NHL"). CTI had requested accelerated approval of its pixantrone NDA for a patient group for which there are no drugs currently approved in this clinical setting. The Office of Oncology Drug Products issued a Complete Response Letter to CTI related to this NDA stating, in part, that CTI's prior clinical trial, PIX301, did not demonstrate efficacy, and that CTI should conduct an additional clinical trial prior to approval. Although CTI is preparing to initiate its PIX306 trial, which would serve as either a post-approval confirmatory trial or a second registration trial for approval, CTI has filed an appeal under the FDA's formal dispute resolution process asking the Office of New Drugs to conclude that PIX301 demonstrated efficacy.

"We believe the FDA diverged from accepted statistical principles and practices when the FDA applied a more stringent statistical significance level in concluding that the PIX301 primary analysis required an adjustment for type 1 error as if an interim analysis had been conducted. This was not the case in the PIX301 trial where only a single final analysis was undertaken," said Richard Kay, PhD, Statistical Consultant, RK Statistics Ltd., Honorary Visiting Professor, School of Pharmacy, Cardiff University. "We believe the results of the PIX301 clinical trial should be analyzed with the appropriate threshold that is standard for trials of this type in which only one efficacy analysis was conducted."

FDA regulations provide a formal dispute resolution process to obtain review of any FDA decision, including a
'/>"/>

SOURCE Cell Therapeutics, Inc.
Copyright©2010 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:4/30/2015)... Calif., April 30, 2015 Omnicell, Inc. (NASDAQ: ... management solutions to healthcare systems, today announced results for ... GAAP results: Revenue for the first quarter of 2015 ... the first quarter of 2014, and down $5.3 million ... First quarter 2015 net income as reported in ...
(Date:4/30/2015)...  Tandem Diabetes Care ® , Inc. (NASDAQ: TNDM ... ® and t:flex™ Insulin Pumps, today reported its financial ... In comparing the first quarter of 2015 to the ... to $12.3 million from $8.1 million , t:slim Pump ... "Our investment in resources to build the foundation ...
(Date:4/30/2015)... April 30, 2015  Cumberland Pharmaceuticals Inc. (NASDAQ: ... quarter 2015 financial results after the market closes on ... Internet webcast will be held on Thursday, May 7, ... results. To participate in the call, please ... callers).  A rebroadcast of the teleconference will be available ...
Breaking Medicine Technology:Omnicell Announces First Quarter 2015 Results 2Omnicell Announces First Quarter 2015 Results 3Omnicell Announces First Quarter 2015 Results 4Omnicell Announces First Quarter 2015 Results 5Omnicell Announces First Quarter 2015 Results 6Omnicell Announces First Quarter 2015 Results 7Omnicell Announces First Quarter 2015 Results 8Omnicell Announces First Quarter 2015 Results 9Omnicell Announces First Quarter 2015 Results 10Omnicell Announces First Quarter 2015 Results 11Omnicell Announces First Quarter 2015 Results 12Omnicell Announces First Quarter 2015 Results 13Omnicell Announces First Quarter 2015 Results 14Omnicell Announces First Quarter 2015 Results 15Omnicell Announces First Quarter 2015 Results 16Omnicell Announces First Quarter 2015 Results 17Omnicell Announces First Quarter 2015 Results 18Omnicell Announces First Quarter 2015 Results 19Omnicell Announces First Quarter 2015 Results 20Omnicell Announces First Quarter 2015 Results 21Omnicell Announces First Quarter 2015 Results 22Omnicell Announces First Quarter 2015 Results 23Omnicell Announces First Quarter 2015 Results 24Omnicell Announces First Quarter 2015 Results 25Omnicell Announces First Quarter 2015 Results 26Omnicell Announces First Quarter 2015 Results 27Tandem Diabetes Care Reports First Quarter 2015 Financial Results 2Tandem Diabetes Care Reports First Quarter 2015 Financial Results 3Tandem Diabetes Care Reports First Quarter 2015 Financial Results 4Tandem Diabetes Care Reports First Quarter 2015 Financial Results 5Tandem Diabetes Care Reports First Quarter 2015 Financial Results 6Cumberland Pharmaceuticals To Announce First Quarter 2015 Financial Results 2
... Begins to Demonstrate Strategy to Expand NHL Marketplace ... Development Program -, BRITISH COLUMBIA, Canada, Sept. ... Bulletin Board: IXSBF;, http://www.ixsbio.com ), a drug development ... on its technology, Dynamic Cross,Linking (DXL(TM)), announced today ...
... Mymetics,Corporation (OTCBB: MYMX), a vaccine development company, ... results on non-human primates,previously immunized with the ... protection. The results significantly exceed the,Industry standard ... considered as a,promising vaccine as well as ...
Cached Medicine Technology:InNexus Lead Candidate DXL625 Outperforms Rituxan in Additional Animal Studies 2InNexus Lead Candidate DXL625 Outperforms Rituxan in Additional Animal Studies 3Successful Results for Mymetics Corporation's Mucosal HIV/AIDS Vaccine Viral Challenge Significantly Exceeds Expectations 2Successful Results for Mymetics Corporation's Mucosal HIV/AIDS Vaccine Viral Challenge Significantly Exceeds Expectations 3Successful Results for Mymetics Corporation's Mucosal HIV/AIDS Vaccine Viral Challenge Significantly Exceeds Expectations 4
(Date:5/3/2015)... 2015 Looking for a graduate ... impact your career? The Master of International Business, ... in multinational companies and for professionals seeking a ... global landscape, differences in culture, religion, government, and ... program develops the global competence and confidence needed ...
(Date:5/3/2015)... May 03, 2015 It is not too late ... Aneurysm Walk in Memory of Lissa Anne Been in Arnold, ... this great family-friendly event to honor her loving memory. It has ... , Just having turned 37, Lissa suffered a brain ... on August 24, 2012. This event is designed to serve as ...
(Date:5/2/2015)... Ticket Down has secured additional inventories of authentic ... today, Saturday, May 2nd at the MGM Grand Garden Arena ... to secure tickets for both the actual fight and various ... wanted for more than five years was finally been agreed ... inside the ring to fight Manny “Pac-Man” Pacquiao in what ...
(Date:5/2/2015)... ProText Kinetic 2 is a set of ... Pro X. ProText Kinetic 2 features 40 animation ... Pro X . Easily create interactive text videos without ... ProText Kinetic 2. , Using ProText Kinetic is as easy ... Kinetic presets in the FCPX timeline. Playback the default ...
(Date:5/2/2015)... “ Peachtree Audio ” was featured on NewsWatch ... the latest and coolest technology products available to consumers. ... NewsWatch, conducted the review and shared with viewers how ... is an important part of people’s lives – and ... royal treatment. Peachtree Audio does just that with high-end ...
Breaking Medicine News(10 mins):Health News:The Saint Louis University's Master of International Business Is Now Enrolling For Fall 2015 2Health News:Renowned Brain Aneurysm Foundation to Benefit from Arnold, Missouri’s 3rd Annual Brain Aneurysm Walk in Memory of Lissa Anne Been 2Health News:Cheap Floyd Mayweather vs. Manny Pacquiao Tickets: Ticket Down Has Last Minute Tickets for Mayweather vs. Pacquiao at the MGM Grand Garden Arena in Las Vegas 2Health News:Cheap Floyd Mayweather vs. Manny Pacquiao Tickets: Ticket Down Has Last Minute Tickets for Mayweather vs. Pacquiao at the MGM Grand Garden Arena in Las Vegas 3Health News:Pixel Film Studios Announced the Release of Protext Kinetic 2 for FPCX. 2Health News:Affordable High-End Audio Equipment was Featured on NewsWatch Television 2
... are a bonus to everyone of us. The first ever ... shows a clear benefit. Angioplasty is a very widely used ... It involves inserting a small balloon into the blood vessel ... vessel apart. The problem is that in 20 per cent ...
... study, in the Journal of Pediatrics, has found a ... a condition that affects one in 500 newborns. ... second month of life, is a blockage of the ... to weight loss and dehydration. It is a common ...
... about siblings? If so, you might have a better memory for ... in a part of the brain called the corpus callosum, which ... family history of left-handedness, says study author Steven Christman. // ... that connects the two sides of our brain and is one ...
... Benckiser has deferred the launch of 'Disprin CV' (cardiovascular) ... painkiller 'Disprin Plus', the company's Regional Director , Mr. ... in the brand-name 'Disprin Plus' to 'Disprin Paracetamol'. Subsequent ... citing instances of concern from doctors and consumers regarding ...
... Risk factors such as insulin resistance and high blood pressure ... as age 14, say researchers according to a recent study. ... to an increased risk of heart attack, stroke and kidney ... related to other heart disease risk factors seen in adolescents, ...
... genetic abnormalities over time and new stem cell lines will ... key stem cell research committee of the National Research Council ... cell divide in a tissue culture it accumulates mutations. In ... cells are unspecialized cells that can become any cell type ...
Cached Medicine News:Health News:Cardiac diseases develop early 2Health News:A need for new stem cell lines 2
Medtronic Aortic Punches are intended for use by cardiac surgeons during coronary artery bypass grafting procedures to create an opening in the wall of the vessel. All punches are sterile and disposa...
... cardioverter defibrillators (ICDs) are designed to treat ... (SCD) due to arrhythmia. The size and ... is designed to facilitate ease of insertion ... 2 system incorporates Guidant's proprietary RHYTHM ID ...
... A-Scan 100 is a compact, portable ultrasound system ... a Windows Laptop or PC computer. The large ... using a single screen eliminating the need for ... , ,The automated features of the A-Scan 100 ...
... designed for fast and simple operation. Tone-assisted ... is aligned & measurements are recorded. The ... use in the IOL calculation. The AL-100 ... accuracy of 0.1mm and a resolution of ...
Medicine Products: