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EMEA Validates Wyeth Application to Expand the European Label of TORISEL
Maidenhead, England (ots/PRNewswire) - Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE), announced today that the European Medicines Agency (EMEA) has validated the marketing authorisation application for Torisel(R) (temsirolimus) for treating relapsed and/or refractory mantle cell lymphoma (MCL), a rare type of non-Hodgkin's lymphoma (NHL) that accounts for approximately 6% of NHL cases and has the lowest five-year survival rate of any lymphoma.
"Relapsed/refactory MCL is an aggressive cancer for which there is no established standard of care in Europe," observed Dr Michael Zaiac, Assistant Vice President, Transplanation, Oncology and GI, Wyeth, Europe Middle East and Africa "If approved for this indication, Torisel could be an important therapeutic option for this patient population, for whom there is at present an unmet medical need."
The EMEA regulatory submission for MCL includes data from a three-arm Phase 3 clinical trial comparing two dose levels of Torisel with the investigators' choice of treatment for patients with relapsed and/or refractory MCL.
Torisel is the only approved cancer therapy that specifically inhibits the mTOR (mammalian target of rapamycin) kinase, an important regulator of cell proliferation, cell growth and cell survival. Having received Orphan Medicinal Product designation in the EU for the treatment of MCL, Torisel was in November 2007 approved in the EU as a first-line treatment for patients with advanced renal cell carcinoma (RCC) who have at least three of six prognostic risk factors.
Together with the continuing development of several other haemato-oncology and oncology products, the development of TORISEL confirms Wyeth's commitment to this important field of medicine.
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 pharmaceutical, 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.
ots Originaltext: Wyeth Pharmaceuticals
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Media Contacts: Wyeth Pharmaceuticals, Gill Markham,