Wyeth has suffered mixed fortunes at the hands of European regulators who have recommended approval for its advanced kidney cancer drug Torisel but turned down the leukaemia treatment Mytolarg.
The company noted that the European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion for Wyeth's Torisel (temsirolimus) as a first-line treatment for patients with advanced renal cell carcinoma who have at least three of six prognostic risk factors.
Full approval is expected in November and the president of Wyeth Research, Robert Ruffolo, said that the approval recommendation “underscores the importance of Torisel, a targeted mTOR (mammalian target of rapamycin) inhibitor “which has been shown to extend median overall survival in patients with advanced kidney cancer when compared with interferon-alpha. It was approved in the USA in May.
However, the CHMP issued a negative opinion for Mylotarg (gemtuzumab ozogamicin) to treat some patients with acute myeloid leukaemia. The committee decided not to recommend approval because only a small number of the 277 patients enrolled in the three main trials of the drug achieved complete remission, and also because there were no data comparing the efficacy of the compound to other products.
Wyeth plans to request a re-examination of the negative opinion, and Dr Ruffalo said that “we believe that Mylotarg is an important drug treatment for AML, and we will continue to work with the CHMP to address the
committee's concerns and pursue a way forward”.