Torisel poised to gain lymphoma licence
pharmafile | February 1, 2008 | News story | Sales and Marketing |
Wyeth's new cancer drug Torisel is set to gain approval for use in patients with a rare and difficult to treat lymphoma.
Torisel (temsirolimus) gained its first approval in November 2007 for use in patients with renal cell carcinoma, but is now one step away from a further approval in relapsed and/or refractory mantle cell lymphoma (MCL), a rare type of non-Hodgkin's lymphoma (NHL).
The European Union has validated its marketing authorisation, meaning it could be finally approved in a matter of weeks.
Relapsed and/or refractory MCL accounts for around six per cent 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," said Dr Michael Zaiac, assistant VP, 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 new use is backed up by data from a three-arm phase III 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 first drug to target and specifically inhibit the mTOR (mammalian target of rapamycin) kinase, an important regulator of cell proliferation, growth and survival.
The drug is also being developed for several other haemato-oncology and oncology indications, and is helping Wyeth extend its presence in the increasingly important cancer market.
Another Wyeth cancer drug Mylotarg, has enjoyed less success than Torisel. Mylotarg is a treatment for acute myeloid leukaemia but was rejected by the EMEA last year because of limited efficacy and evidence base.
