Roche and Genentech are continuing in their mission to dominate the global oncology market and this morning said they have filed for US approval of the anti-angiogenesis cancer drug Avastin (bevacizumab) to treat women with advanced breast cancer.
The move follows data showing the drug doubled survival time when added to conventional chemotherapy and looks set to significantly expand the brand's potential; it is currently marketed for advanced colorectal cancer, pulling 1.7 billion Swiss francs ($1.3 billion) into Roche's coffers during 2005, its first full year on the market, and in April was filed with the US Food and Drug Administration for use in non-small cell lung cancer.
Specifically, the firms are seeking a nod for the use of Avastin in combination with the taxane class of oncologic therapies - for example, Bristol-Myers Sqiubb's Taxol (paclitaxel) - as a first treatment choice for women in advanced stages of the disease. A decision could come as soon as November, as Roche and Genentech have requested the dossier be given priority review; this would mean a six-month review period from filing.
And Roche and Genentech are not resting on their laurels in their drive to ramp up their successful oncology portfolio: in addition to plans to file for European approval later this year in advanced breast cancer, the firms are also investigating Avastin's potential in ovarian, pancreatic and renal cell carcinoma, as well as in various different treatment settings. The total development programme is forecast to include some 25,000 patients worldwide.
Earlier this week, they unveiled plans to re-start a Phase III trial of Avastin in colon cancer. The so-called AVANT study was halted in February because of a small number of fatalities, including some sudden cardiac deaths, but an independent data monitoring committee has now concluded that the fatality rates were consistent to that seen in other colon cancer trials. However, as a consequence, Roche/Genentech will now introduce cardiac monitoring into the trials.
The companies will certainly be pleased to see this black cloud dissipating; Avastin has been described as a pipeline in a product with sales this year expected to reach a not-insignificant 3 billion Swiss francs.