Wyeth Europa, a division of Wyeth (NYSE:WYE), announced today that it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) recommending the approval of the mTOR (mammalian target of rapamycin) inhibitor TORISEL(R) (temsirolimus) for the treatment of relapsed and/or refractory mantle cell lymphoma (MCL). The CHMP's opinion will now be forwarded to the European Commission for a final decision. 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 European Union (EU) in November 2006.
"Mantle cell lymphoma that has relapsed or is refractory to other therapies is extremely difficult to treat," says Mikael Dolsten, M.D., Ph.D., President, Wyeth Research. "The CHMP's positive opinion underscores the potential for TORISEL to provide an important therapeutic option for patients in the European Union with this disease."
The positive opinion 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, anaemia, neutropenia and asthenia.
TORISEL, a cancer therapy that specifically inhibits the mTOR kinase, an important regulator of cell proliferation, cell growth and cell survival, was approved in the EU in November 2007 for the first-line treatment for patients with advanced renal cell carcinoma (RCC) who have at least three of six prognostic risk factors. 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.
Please see TORISEL full product information. Available on request.
Wyeth Europa, as part of 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, haemophilia, 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.
Media Contacts: Wyeth Europa, Gill Markham, 27 Jul. (0) - 1628-692536