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Home Industry News Roche announces positive opinion for Herceptin

Roche announces positive opinion for Herceptin

26th March 2007

Roche’s Herceptin this week became the first breast cancer drug to receive a positive opinion from the European Union for use in combination with an aromatase inhibitor.

The Swiss pharmaceutical company announced this morning that the EU’s Committee for Human Medicinal Products (CHMP) has given a positive recommendation for the use of Herceptin along with an aromatase inhibitor in postmenopausal patients with HER2 and hormone receptor-positive metastatic breast cancer.

The CHMP’s recommendation is based on data collected from the international phase III TAnDEM study.

The recommendation for Herceptin is particularly significant, Roche argues, because the TAnDEM study has shown conclusively for the first time that patients who are both HER2 and hormone receptor-positive are an especially high-risk group.

Previous research has shown that around two thirds of breast tumours are hormone receptor-postive, while a quarter of these are also HER2-positive.

Eduard Holdener, chief medical officer of Roche, welcomed the EU’s endorsement, saying: “This combination offers a new treatment regimen for patients who suffer from a particularly aggressive form of breast cancer, and we are pleased to have been able to progress this application so quickly.”

The TAnDEM study found that the use of Herceptin alongside hormone therapy (anastrozole) doubled median progression-free survival times from 2.4 to 4.8 months as against the use of anastrozole alone.

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