The European Commission has approved Wyeth’s mTOR (mammalian target of rapamycin) inhibitor Torisel (temsirolimus) for the treatment of adult patients with relapsed and/or refractory mantle cell lymphoma (MCL).
In the 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,” said Mikael Dolsten, 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 per cent 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 the results of a phase III 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).
“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,” said Georg Hess, MD, Johannes Gutenberg-Universitat, Mainz, Germany, an investigator in the Torisel phase III clinical programme.