September meeting to focus on use of Zevalin as consolidation therapy after remission induction in previously untreated patients with follicular lymphoma SEATTLE, July 22
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-naïve, 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.
