There was good news for Roche’s breast cancer drug Herceptin from both sides of the globe yesterday, as the UK’s National Institute for Health and Clinical Excellence and regulators in Australia gave the final seal of approval for funding the drug’s use for early-stage breast cancer.

“These decisions confirm Roche’s belief that Herceptin provides a significant advance in the effective treatment of women with HER 2 positive breast cancer,” commented Svend Petersen, Managing Director of Roche Products (New Zealand). And announcing the UK decision, NICE Chief Executive Andrew Dillon said Herceptin was clearly "clinically and cost effective."

Herceptin (trastuzumab) won approval in Europe back in 2000, but has, until now, only been recommended in the UK for the treatment of metastatic cancer. Therefore, this latest guidance will allow a much larger set of patients access to the drug, thereby substantially widening its market.

Around 20% to 30% of breast cancers are HER2-positive, and Herceptin is already Roche's third-biggest product, bringing in around $1.8 billion in sales last year, almost 50% ahead of 2004's tally.

NICE had been expected to come out in favour of Herceptin, as there has been relentless pressure on the agency from all sides to expand access to the drug. Women have been taking to the courts to force their primary care trusts to pay for the drug, and Health Secretary Patricia Hewitt has also put her weight behind drive, asking NICE to fast-track the application.

But the news was not so good in the US, where Genentech, Roche’s partner and discoverer of the drug, recently faced a setback in getting approval for the early-stage setting after the Food and Drug Administration said it will have to wait up to three months for decision.

The FDA asked for more time to review the dossier after Genentech submitted additional information - a re-analysis of data from previously-submitted studies - which the agency has classified as a 'major amendment' to the file.