As reported by Reuters, Ã¢â‚¬Å“a number of sudden deathsÃ¢â‚¬Â has prompted Roche Holding AG and Genentech to Ã¢â‚¬Å“temporarily suspend recruitment of patients into a clinical trial assessing the use of colon cancer drug Avastin after surgery.Ã¢â‚¬Â
The trial is designed to see how patients respond when given either conventional chemotherapy drugs or an Avastin-based combination. The Phase III trial that goes by the name AVANT, is a final-stage test meaning the drug was nearing the point when a New Drug Application would have been expected.
The company said on Monday that its Ã¢â‚¬Å“broad oncology program,Ã¢â‚¬Â which it is working on with majority-owned Genentech, remained Ã¢â‚¬Å“on trackÃ¢â‚¬Â despite the suspension.
According to the Reuters report, William Burns, Roche’s head of pharmaceuticals, said the decision would not cause a financial impact. “No, none at all because the hypothesis for the trial is a hypothesis … and the financial community does not know whether it is going to play out or not play out,” he told Reuters in a telephone interview.
But some analysts believe the suspension will be unsettling for investors, given Roche’s high valuation, which is largely based Ã¢â‚¬Å“on the success of its cancer business.Ã¢â‚¬Â
“While numbers are unlikely to change it raises the risk that Avastin will not be approved in further indications or that off-label use will be more limited,” they noted.
Newsinferno.com is following this breaking story and will have a follow-up as soon as details become available.