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Wyeth Pharmaceuticals

Wyeth's Torisel Approved by European Commission for the Treatment of Relapsed and/or Refractory Mantle Cell Lymphoma

Maidenhead, England (ots/PRNewswire)

Wyeth Europa Ltd.,
a division of Wyeth (NYSE: WYE), announced today that the European
Commission has approved the mTOR (mammalian target of rapamycin)
inhibitor TORISEL(R) (temsirolimus) for the treatment of adult
patients with relapsed and/or refractory mantle cell lymphoma (MCL).
In the European Union (EU), TORISEL is also indicated for the
first-line treatment of patients with advanced renal cell carcinoma
who have at least three of six prognostic risk factors.
"With this approval, TORISEL will now be available to benefit
patients with relapsed or refractory mantle cell lymphoma, for which
there are few treatment options," says Mikael Dolsten, M.D., Ph.D.,
President, Wyeth Research. "Wyeth is committed to providing
much-needed medicines to patients with rare and difficult-to-treat
diseases."
MCL is a rare type of non-Hodgkin's lymphoma (NHL) that accounts
for approximately 6 percent of NHL cases and has the lowest five-year
survival of any type of lymphoma. TORISEL received Orphan Medicinal
Product designation for the treatment of MCL in the EU in November
2006.
The approval was based on results of a phase 3 clinical study
that showed patients with relapsed and/or refractory MCL treated with
TORISEL experienced a statistically significant improvement in median
progression-free survival, compared with single-agent therapy
selected by the investigator (4.8 months vs. 1.9 months, P=0.0009).
The most frequently occurring severe or life-threatening (Grade 3 or
4) adverse events in patients with relapsed MCL treated with TORISEL
included thrombocytopenia, anemia, neutropenia and asthenia.5
"Relapsed and refractory mantle cell lymphoma is a
difficult-to-treat disease, and the ability of TORISEL to improve
progression-free survival makes it an important new therapeutic
option for patients living with this condition," says Georg Hess,
M.D., Johannes Gutenberg-Universitat, Mainz, Germany, and an
investigator in the TORISEL phase 3 clinical program for TORISEL.
About TORISEL
TORISEL specifically inhibits the mTOR kinase, an important
regulator of cell proliferation, cell growth and cell survival.
TORISEL was approved in the EU in November 2007 for the first-line
treatment for patients with advanced RCC who have at least three of
six prognostic risk factors. These risk factors include less than one
year from time of initial RCC diagnosis to randomization, Karnofsky
performance status of 60 or 70, hemoglobin less than the lower limit
of normal, corrected calcium of greater than 10 mg/dL, lactate
dehydrogenase >1.5 times the upper limit of normal and more than one
metastatic organ site. In the United States, TORISEL is indicated for
the treatment of patients with advanced RCC.
Inhibition of mTOR in treated cancer cells blocked the
translation of genes that regulate the cell cycle. In in vitro
studies using renal cancer cell lines, temsirolimus inhibited the
activity of mTOR and resulted in reduced levels of the
hypoxia-inducible factors HIF-1 and HIF-2 alpha, and the vascular
endothelial growth factor.
Wyeth Pharmaceuticals
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
products.
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 nutritionals 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. For additional information about the Company, please visit
http://www.wyeth.com.

Contact:

Media Contact: Wyeth Pharmaceuticals, Gill Markham, +44(0)1628-692536

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