Swiss drugmaker Roche will resume patient recruitment into its Phase III clinical trial of Avastin in colon cancer, which was halted in February after a number of fatalities, including some sudden cardiac deaths.
Recruitment in the AVANT study, which is assessing the drug's efficacy in preventing colon cancer recurrence following surgery, was stopped as it emerged that more deaths had occurred in patients taking Avastin and Xelox - a combination of Roche's Xeloda (capecitabine) and Sanofi-Aventis' cancer drug Eloxatin (oxaliplatin) compared to those receiving a regimen of Avastin and a standard chemotherapy regimen (known as Folfox) or Folfox alone.
Roche said that the trial’s independent monitoring board had concluded after a review of the data that death rates in AVANT were consistent with those seen in other colon cancer trials. However, as a precaution the company has decided to amend the protocol to include cardiac monitoring of enrolled patients.
The news is a relief to Roche as Avastin is one of its fastest growing products and was the first drug to be approved in a new class of cancer agents that work by inhibiting the formation of blood vessels to tumours.
Referred to by some as ‘a pipeline in a product’ due to its potential application across a spectrum of tumour types, Avastin, which is marketed in the USA by Genentech, pulled in sales of 1.7 billion Swiss francs ($1.3 billion) for Roche in 2005 - its first full year on the market – and looks set to approach 3 billion this year.