Navigation Links
CTI to Meet With the FDA to Discuss Filing of a Supplemental Biologics License Application for Zevalin(R)
Date:7/21/2008

September meeting to focus on use of Zevalin as consolidation therapy after

remission induction in previously untreated patients with follicular

lymphoma

SEATTLE, July 22 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced today that the Company has scheduled a meeting with the U.S. Food and Drug Administration (FDA) in September to discuss the possibility of filing a supplemental Biologics License Application (sBLA) for use of Zevalin(R) ([90Y]-ibritumomab tiuxetan) as consolidation therapy after remission induction in previously untreated patients with follicular non-Hodgkin's lymphoma. The basis for the filing would be data from the First-line Indolent Trial that CTI recently gained access to through an agreement with Bayer Schering Pharma.

"We are pleased to have scheduled a meeting with the FDA to discuss a label expansion for Zevalin which could broaden its availability to patients," said James A. Bianco, M.D., President and CEO of Cell Therapeutics. "We continue to make progress with Zevalin on multiple fronts with clarity on reimbursement rates, deployment of our national sales team and now the opportunity to meet with the FDA to discuss possibly expanding the label for Zevalin."

About the Phase III First-line Indolent (FIT) Trial

The multinational, randomized phase III First-line Indolent Trial (FIT) evaluated the benefit and safety of a single infusion of Zevalin in patients with CD20-positive follicular non-Hodgkin's lymphoma who had achieved a partial response or a complete response after receiving standard first-line chemotherapy regimens. The FIT trial results were presented in one oral and two poster presentations at the American Society of Hematology (ASH) conference in December 2007. The FIT trial demonstrated that when used as a first-line consolidation therapy for patients with follicular non-Hodgkin's lymphoma, Zevalin significantly improved the median progression-free survival time from 13.5 months (control arm) to 37 months (p<0.0001).

The primary investigators of the study concluded that Zevalin consolidation of first remission in advanced stage follicular non-Hodgkin's lymphoma is highly effective, resulting in a total complete response (CR + CRu) rate of 87 percent and prolongation of median progression-free survival (PFS) by approximately two years, with a toxicity profile comparable to that seen with Zevalin's use in approved indications. Zevalin-treated patients had reversible Grade 3 or 4 hematologic side effects including neutropenia in 67 percent, thrombocytopenia in 61 percent, and anemia in 3 percent. Nonhematologic toxicities were 24% Grade 3, 5% Grade 4, and Grade 3/4 infection was 8%.

About Zevalin(R)

Zevalin(R) (Ibritumomab Tiuxetan) is a form of cancer therapy called radioimmunotherapy and is indicated as part of the Zevalin therapeutic regimen for treatment of relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma, including patients with rituximab refractory follicular NHL. Zevalin is indicated under accelerated approval for the treatment of relapsed or refractory, rituximab-nave, low-grade and follicular NHL based on studies using a surrogate endpoint of overall response rate. It was approved by the FDA in February of 2002 as the first radioimmunotherapeutic agent for the treatment of NHL.

Rare deaths associated with an infusion reaction symptom complex have occurred within 24 hours of rituximab (Rituxan(R)) infusions. Yttrium-90 Zevalin administration results in severe and prolonged cytopenias in most patients. Severe cutaneous and mucocutaneous reactions have been reported. The most serious adverse reactions of the Zevalin therapeutic regimen were primarily hematologic, including neutropenia, thrombocytopenia and anemia. Infusion-related toxicities were associated with pre-administration of rituximab. The risk of hematologic toxicity correlated with the degree of bone marrow involvement prior to Zevalin therapy. Myelodysplasia or acute myelogenous leukemia was observed in 2 percent of patients (8 to 34 months after treatment). Zevalin should only be used by health care professionals qualified by training and experience in the safe use of radionuclides.

Patients and healthcare professionals can visit http://www.zevalin.com for more information.

About Non-Hodgkin's Lymphoma

Non-Hodgkin's lymphoma (NHL) is caused by the abnormal proliferation of white blood cells and normally spreads through the lymphatic system, a system of vessels that drains fluid from the body. NHL can be broadly classified into two main forms -- aggressive NHL, a rapidly spreading acute form of the disease, and indolent NHL, which progresses more slowly. According to the National Cancer Institute's SEER database there were nearly 400,000 people in the U.S. with NHL in 2004. The American Cancer Society estimates that 66,120 people will be diagnosed with NHL in 2008 and more than 19,000 are expected to die.

About Cell Therapeutics, Inc.

Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit http://www.celltherapeutics.com.

This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results. Specifically, the risks and uncertainties that could affect the development of Zevalin include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with Zevalin in particular including, without limitation, the potential failure of the Zevalin FIT data to be suitable for submission or acceptable to the FDA for this expanded indication or any other indication, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, and costs of developing, producing and selling Zevalin. There is also a risk that even if label expansion of Zevalin is approved, it may not result in a significant market increase for the drug due to the presence of other treatment options, failure to gain market acceptance and other factors. In addition, there is a risk that we may not be able to recognize the full expected value of Zevalin in future years. You should also review the risk factors listed or described from time to time in the Company's filings with the Securities and Exchange Commission including, without limitation, the Company's most recent filings on Forms 10-K, 8-K, and 10-Q. Except as may be required by law, CTI does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.

Media Contact:

Dan Eramian

T: 206.272.4343

C: 206.854.1200

E: media@ctiseattle.com

http://www.CellTherapeutics.com/media.htm

Investors Contact:

Ed Bell

T: 206.272.4345

Lindsey Jesch

T : 206.272.4347

F : 206.272.4434

E: invest@ctiseattle.com

http://www.CellTherapeutics.com/investors.htm


'/>"/>
SOURCE Cell Therapeutics, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Public Forum to Discuss Addiction as a Treatable Disease and Highlight National Alcohol and Drug Addiction Recovery Month
2. Cell Therapeutics, Inc. (CTI) Sponsors Panel Discussion on Women and Lung Cancer on Capitol Hill
3. Cell Therapeutics, Inc. (CTI) Supports Panel Discussion on Women and Lung Cancer on Capitol Hill
4. Threshold to Host Conference Call to Discuss Results From Clinical Presentations at European Cancer Conference (ECCO)
5. Most Women With HIV and Their Health Care Providers Have Not Discussed How HIV Might Affect Them Differently Than Men
6. APIC Conference to Discuss MRSA Elimination
7. ReachMD Broadcasts First-of-its-Kind Physician Peer-Peer Discussion on ENHANCE Trial
8. Mayo Clinic Proceedings Contributors Discuss Impact of Donor Organ Allocation System
9. Rigel to Host Conference Call to Discuss Preliminary Phase 2 Study Results of R788 in Lymphoma
10. Cell Therapeutics, Inc. (CTI) to Hold Conference Call to Discuss Agreement With Bayer Schering Pharma for Access to Phase III Zevalin(R) FIT Trial Data
11. Medivation to Host Conference Call at 5 p.m. EDT Monday to Discuss Top-Line Phase 2 Study Results in Huntingtons Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... , June 23, 2016 ... CAPR ), a biotechnology company focused on ... today announced that patient enrollment in its ongoing ... Duchenne) has exceeded 50% of its 24-patient target. ... in the third quarter of 2016, and to ...
(Date:6/23/2016)... , June 23, 2016 Bracket , ... launch its next generation clinical outcomes platform, Bracket eCOA (SM) ... held on June 26 – 30, 2016 in ... first electronic Clinical Outcome Assessment product of its kind to ... #715. Bracket eCOA 6.0 is a flexible platform ...
(Date:6/23/2016)... PARK RIDGE, Ill. and INDIANAPOLIS ... caliber of students receiving a Lilly Diabetes Tomorrow,s Leaders ... hands. The 2016 scholarship winners, announced today online at ... refused to let type 1 diabetes stand in the ... Lilly Diabetes has supported the Foundation,s scholarship program since ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... 2016 , ... TherapySites, the leading website and ... Tennessee Counseling Association. This new relationship allows TherapySites to continue to extend ... exclusive benefits and promotional offers. , "TCA is extremely excited about this new ...
(Date:6/27/2016)... , ... June 27, 2016 , ... ... edge technology to revolutionize the emergency ambulance transport experience for the millions of ... of how Uber has disrupted the taxi industry through the use of technology. ...
(Date:6/26/2016)... ... June 27, 2016 , ... Quality metrics are proliferating in cancer care, ... remain in the eye of the beholder, according to experts who offered insights and ... Journal of Managed Care. For the full issue, click here . , For ...
(Date:6/26/2016)... ... ... Pixel Film Studios Released ProSlice Levels, a Media Slicing Effect Plugin ... whole new perspective by using the title layers in ProSlice Levels to split-up ... Levels contains over 30 Different presets to choose from. FCPX users can ...
(Date:6/26/2016)... ... ... legally blind and certified personal trainer is helping to develop a weight loss fitness plan ... fix the two major problems leading the fitness industry today:, , ... They don’t eliminate all the reasons people quit their exercise program ...
Breaking Medicine News(10 mins):