Roche's Herceptin for metastatic gastric cancer rejected by UK's NICE; drugmaker files BLA for additional use of the drug

In preliminary draft guidance issued for public consultation today, the UK's National Health Service treatment watchdog, the National Institute for Health and Clinical Excellence (NICE) has turned down another expensive cancer drug, saying it has been unable to recommend Swiss drug major Roche's Herceptin (trastuzumab) for gastric cancer due to the uncertainty surrounding the extent to which to which it can extend life.

Gastric, or stomach, cancer affects 8,200 people in the UK every year - of whom approximately 500 would be eligible for treatment with trastuzumab. In its draft guidance, NICE has not recommended trastuzumab, in combination with cisplatin and capecitabine or 5-fluorouracil for the treatment of people with HER2-positive metastatic gastric cancer.

Andrew Dillon, Chief Executive of NICE said: 'Although clinical trials suggest that trastuzumab can extend life for patients with HER2-positive metastatic gastric cancer, there is considerable uncertainty about the data on how long this extension would be. The manufacturer and other consultees now have an opportunity to help the independent Appraisal Committee resolve this uncertainty, to the extent that they can. All comments received will be fully considered by the Committee at their next meeting.'