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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.
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, 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.
ots Originaltext: Wyeth Pharmaceuticals
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