Navigation Links
CTI to Meet With the FDA to Discuss Filing of a Supplemental Biologics License Application for Zevalin(R)

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

remission induction in previously untreated patients with follicular


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 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

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


Investors Contact:

Ed Bell

T: 206.272.4345

Lindsey Jesch

T : 206.272.4347

F : 206.272.4434


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:
(Date:11/24/2015)...  Array BioPharma Inc. (Nasdaq: ARRY ) ... Ron Squarer , will present at the Piper ... public is welcome to participate in the conference ... Jaffray Annual Healthcare ConferencePresenter:  , Ron Squarer, Chief ... Eastern Time Webcast: , ...
(Date:11/24/2015)... NEWPORT NEWS, Va. , Nov. 24, 2015 /PRNewswire/ ... that they have signed an agreement for DILON to ... select geographies across the globe. The signing of this distribution ... GE,s Discovery NM750b Molecular Breast Imaging system and is ... ways to provide better healthcare solutions for clinicians and ...
(Date:11/24/2015)... 2015 . ... adds Latest Guidebook for Chinese Medical Device GMP ... in November 2015 to the medical devices market ... at . China ... global economies with a fifth population in the ...
Breaking Medicine Technology:
(Date:11/25/2015)... , ... November 25, 2015 , ... “While riding the ... inventor, from Bronx, N.Y. “I thought there had to be a convenient and comfortable ... PROTECTOR. , The PROTECTOR enables disabled individuals to safely travel during cold or inclement ...
(Date:11/25/2015)... ... November 25, 2015 , ... ... that it has undertaken significant expansion of its current state of the art ... part of PharmaTech’s strategy to increase its manufacturing capacity as well as to ...
(Date:11/25/2015)... ... November 25, 2015 , ... Students and parents have something to be thankful ... Create Real Impact awards. California Casualty is proud to support the contest ... distracted and reckless driving, the number one killer of young drivers. , Almost ...
(Date:11/24/2015)... ... ... New patients who wish to seek treatment for missing teeth can now visit ... ON practice. Dr. Williams has been providing dental service for over 34 years, and ... can lead to a variety of complications if they are not replaced quickly, including ...
(Date:11/24/2015)... ... November 25, 2015 , ... ... development solutions for drugs, biologics, consumer health and global clinical supply services, today ... the upcoming Clinical Trial Supply East Asia Conference, to be held at the ...
Breaking Medicine News(10 mins):