Supplemental Biologics License Application (sBLA) on track for Q4
SEATTLE, Sept. 22 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTICD and MTA: CTIC) announced today that following a meeting with the U.S. Food and Drug Administration (FDA) data from the First-line Indolent Trial (FIT) would be sufficient to support a submission for a supplemental Biologics License Application (sBLA). The sBLA will propose a label expansion to include use of the Zevalin(R) therapeutic regimen ([90Y]-ibritumomab tiuxetan) as consolidation therapy after remission induction in previously untreated patients with follicular non-Hodgkin's lymphoma. The Company plans to submit the sBLA in the fourth quarter and request priority review, which if granted, would result in a six month review period. CTI gained access to the FIT data through an agreement with Bayer Schering Pharma who used the data to obtain approval for Zevalin as first-line consolidation treatment in Europe.
"We are pleased with the collegial interaction with the FDA and their guidance on our plan for submitting the FIT trial results to expand the Zevalin label," said James A. Bianco, M.D., CEO of Cell Therapeutics. "Label expansion for first-line indication would make this important treatment option available to the tens of thousands of patients who may benefit."
Zevalin is currently approved in the United States for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL), including patients with rituximab refractory follicular NHL. Zevalin is also indicated, under accelerated approval, for the treatment of relapsed or refractory, rituximab-naive, low-grade and follicular NHL based on studies using an endpoint of overall response rate, which is a surrogate for progression free survival.
"Radioimmunotherapies are currently underutilized in the treatment of non-Hodgkin's lymphoma patients, especially among community oncologists despite clinical data supporting broader use," said Fredrick Hagemeister, M.D., Professor of Medicine at the University of Texas M.D. Anderson Cancer Center. "Zevalin is an important treatment option for patients with follicular lymphoma and I would look forward to the FDA's approving its use in first-line consolidation therapy as it has been approved in Europe and has benefited patients from its use in this way."
About First-Line Consolidation Therapy
Consolidation therapy is a treatment given after initial induction therapy and is aimed to improve the quality of the patient response by further diminishing the number of cancer cells with the goal of extending the response duration.
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 414 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 for the first time in one oral and three 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 (Zevalin arm) (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 of patients. Nonhematologic toxicities were 24% Grade 3, 5% Grade 4, and Grade 3/4 infection was 8%.
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 also indicated, under accelerated approval, for the treatment of relapsed or refractory, rituximab-naive, 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 for Zevalin FIT data to be
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. 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.
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|SOURCE Cell Therapeutics, Inc.|
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