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.
Source
Wyeth Pharmaceuticals
View drug information on Torisel.