Question to the Department of Health and Social Care:

To ask Her Majesty's Government whether there are (1) current applications, or (2) pending requests, for the use of Avastin following Phase 3 clinical trials.

To extend the indication of Avastin, the Marketing Authorisation Holder (Roche Registration GmbH) would need to submit the results of relevant clinical trials and other information to the European Medicines Agency (EMA) to demonstrate acceptable safety and efficacy and a positive balance of benefit to risk. At present, as Avastin has a European Community Marketing Authorisation, a national submission to the Medicines and Healthcare products Regulatory Agency to extend the indication is not possible.

There has not been any recent positive opinion from the EMA for a new indication of Avastin to be submitted to the European Commission and the EMA has not published any pending extension of indication applications.