Collegeville, Pennsylvania (ots/PRNewswire)
- TORISEL Is Proven to Extend Overall Survival for People with
Advanced Renal Cell Carcinoma -
Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced
today that the U.S. Food and Drug Administration (FDA) has approved
TORISEL(TM) (temsirolimus) for patients with advanced renal cell
carcinoma (RCC). TORISEL is the first targeted renal cancer therapy
proven to extend median overall survival versus interferon-alpha, an
active comparator, in this patient population.
Renal cell carcinoma accounts for approximately 85 percent of
kidney cancers. The American Cancer Society estimates that 51,190 new
cases of kidney cancer will be diagnosed this year, and more than 40
percent of these patients are initially diagnosed with advanced
disease. TORISEL is the only marketed cancer therapy that
specifically inhibits the mTOR (mammalian target of rapamycin)
kinase, a key protein in cells that regulates cell proliferation,
cell growth and cell survival. Wyeth anticipates that TORISEL will be
available to patients in July 2007.
As part of a postmarketing commitment, Wyeth has agreed to submit
two completed study reports and data sets: one on a thorough QT
prolongation study and one on an ongoing hepatic impairment study.
"Advanced renal cell carcinoma can be a devastating diagnosis for
patients and their families because the disease is very difficult to
treat," says Gary Hudes, M.D., Director, Genitourinary Malignancies
Program, Fox Chase Cancer Center, Philadelphia, and lead investigator
of the phase 3 trial of TORISEL in advanced RCC. "Developing
effective treatments for this stage of disease is a major challenge.
Temsirolimus is the first drug to demonstrate a significant increase
in overall survival for patients with the most aggressive form of
kidney cancer, providing us with a new and much needed option for
In a three-arm, phase 3 clinical trial of 626 patients with
advanced RCC and poor prognosis who had received no prior systemic
therapy, TORISEL significantly increased median overall survival by
49 percent compared to interferon-alpha (10.9 months vs. 7.3 months,
P=0.0078). TORISEL also was associated with a statistically
significant improvement over interferon-alpha in the secondary
endpoint of progression-free survival (when the disease does not get
worse; 5.5 months vs. 3.1 months, P=0.0001). The combination of
TORISEL and interferon-alpha did not result in a significant increase
in overall survival when compared with interferon-alpha alone.
"The approval of TORISEL for the treatment of advanced renal cell
carcinoma reinforces the potential of mTOR inhibition as a new
approach in oncology. This milestone demonstrates Wyeth's commitment
to developing innovative therapies for cancer. In addition to
TORISEL, we have five oncology treatments currently in human trials
for various cancers, and we are dedicated to research into new
therapies that have the potential to address unmet medical needs,"
says Robert R. Ruffolo, Ph.D., President, Wyeth Research.
TORISEL is an mTOR inhibitor indicated for the treatment of
advanced RCC. In in vitro studies using cancer cells, mTOR inhibition
blocked the translation of genes that regulate the cell cycle. mTOR
inhibition also resulted in reduced levels of certain cell growth
factors involved in the development of new blood vessels, such as
vascular endothelial growth factor.
Important Safety Information
Hypersensitivity reactions manifested by symptoms, including, but
not limited to anaphylaxis, dyspnea, flushing, and chest pain have
been observed with Torisel.
The use of Torisel is likely to result in increases in serum
glucose. This may result in the need for an increase in the dose of,
or initiation of, insulin and/or oral hypoglycemic agent therapy. The
use of Torisel is likely to result in increases in serum
triglycerides and cholesterol. This may require initiation, or
increase in the dose, of lipid-lowering agents.
The use of Torisel may result in immunosuppression. Patients
should be carefully observed for the occurrence of infections,
including opportunistic infections.
Cases of interstitial lung disease, some resulting in death, have
occurred with Torisel. Some patients were asymptomatic and others
presented with symptoms and required discontinuation of Torisel
treatment and/or corticosteroids, and/or antibiotics.
Bowel perforation may occur. Evaluate fever, abdominal pain,
bloody stools and/or acute abdomen promptly.
Renal failure, sometimes fatal, has occurred. Monitor renal
function at baseline and while on Torisel.
Due to abnormal wound healing, use Torisel with caution in the
Patients with central nervous system tumors (primary CNS tumor or
metastases) and/or receiving anticoagulation therapy may be at an
increased risk of developing intracerebral bleeding (including fatal
outcomes) while receiving Torisel.
Live vaccinations and close contact with those who received live
vaccines should be avoided.
Women of childbearing potential should be advised of the potential
hazard to the fetus and to avoid becoming pregnant.
The most common (incidence greater than or equal to 30%) adverse
reactions observed with Torisel are: rash, asthenia, mucositis,
nausea, edema, and anorexia. The most common laboratory abnormalities
(incidence greater than or equal to 30%) are anemia, hyperglycemia,
hyperlipemia, hypertriglyceridemia, elevated alkaline phosphatase,
elevated serum creatinine, lymphopenia, hypophosphatemia,
thrombocytopenia, elevated AST, and leukopenia.
Strong inducers of CYP3A4/5 and inhibitors of CYP3A4 may affect
concentrations of the primary metabolite of Torisel. If alternatives
cannot be used, dose modifications of Torisel are recommended.
Please see TORISEL full prescribing information at
TORISEL Development Program
Wyeth continues to study TORISEL in a phase 3 trial of patients
with mantle cell lymphoma, which is an aggressive type of B-cell
non-Hodgkin's lymphoma, and the Company is pursuing several
additional studies in RCC. Additional oncology trials with TORISEL
are being conducted through a cooperative research and development
agreement with the National Cancer Institute in several other tumor
Wyeth Pharmaceuticals, a division of Wyeth, has leading products
in the areas of women's health care, infectious disease,
gastrointestinal health, central nervous system, inflammation,
transplantation, hemophilia, oncology, vaccines and nutritional
Wyeth is one of the world's largest research-driven pharmaceutical
and health care products companies. It is a leader in the discovery,
development, manufacturing and marketing of pharmaceuticals,
vaccines, biotechnology products and non-prescription medicines that
improve the quality of life for people worldwide. The Company's major
divisions include Wyeth Pharmaceuticals , Wyeth Consumer Healthcare
and Fort Dodge Animal Health.
The statements in this press release that are not historical facts
are forward-looking statements based on current expectations of
future events and are subject to risks and uncertainties that could
cause actual results to differ materially from those expressed or
implied by such statements. These risks and uncertainties include the
inherent uncertainty of the timing and success of, and expense
associated with, research, development, regulatory approval and
commercialization of our products, including with respect to our
pipeline products; government cost-containment initiatives;
restrictions on third-party payments for our products; substantial
competition in our industry, including from branded and generic
products; data generated on our products; the importance of strong
performance from our principal products and our anticipated new
product introductions; the highly regulated nature of our business;
product liability, intellectual property and other litigation risks
and environmental liabilities; uncertainty regarding our intellectual
property rights and those of others; difficulties associated with,
and regulatory compliance with respect to, manufacturing of our
products; risks associated with our strategic relationships; economic
conditions including interest and currency exchange rate
fluctuations; changes in generally accepted accounting principles;
trade buying patterns; the impact of legislation and regulatory
compliance; risks and uncertainties associated with global operations
and sales; and other risks and uncertainties, including those
detailed from time to time in our periodic reports filed with the
Securities and Exchange Commission, including our current reports on
Form 8-K, quarterly reports on Form 10-Q and annual report on Form
10-K, particularly the discussion under the caption "Item 1A, Risk
Factors." The forward-looking statements in this press release are
qualified by these risk factors. We assume no obligation to publicly
update any forward-looking statements, whether as a result of new
information, future developments or otherwise.
Web site: http://www.wyeth.com
ots Originaltext: Wyeth Pharmaceuticals
Im Internet recherchierbar: http://www.presseportal.ch
Media, Candace Steele of Wyeth Pharmaceuticals, +1-484-865-5428; or
Douglas Petkus, +1-973-660-5218, or Investors, Justin Victoria,
+1-973-660-5340, both of Wyeth