GlaxoSmithKline PLC has filed for permission with European medicine regulators to begin selling its new breast cancer pill Tykerb.
This follows a similar move in the US last month, and comes slightly earlier than some commentators were expecting.
The drug is foreseen to be one of GSK's most promising pipeline drugs as well as a potential blockbuster. According to analysts at Nomura Code the sales of the drug could cross 2 bln used by 2010.
GSK, Europe's biggest pharmaceutical company has given an application for a license to market the drug as a treatment for advanced breast cancer wherein cancer has spread to other parts of the body. It is to be taken in combination with the chemotherapy agent Xeloda, made by Roche Holdings AG.
Possible candidates for the treatment are women who failed to respond to Roche's and Genentech Inc's drug Herceptin.
While Tykerb is taken daily in a pill form, Herceptin is given as injections every month.
Clinical trials showed a longer time to disease progression among women taking Tykerb, almost double that seen among those receiving e chemotherapy agent alone.
Positive results caused an early end to the trial.
According to GSK over 360,000 new cases of breast cancer are diagnosed every year in Europe, and around half of those women will go on to develop advanced, or metastatic disease.