Roche asks European Medicines Agency for authorization to market Herceptin

Roche on Friday announced it has submitted an application with the European Medicines Agency to market its breast cancer drug Herceptin as a treatment for women living with an aggressive form of advanced-stage breast cancer, called HER2-positive, and hormone receptor-positive breast cancer, AFX/Forbes reports (AFX/Forbes, 10/13).

The request comes shortly after results of a Phase III clinical trial sponsored by Roche examining Herceptin and AstraZeneca's Arimidex were released earlier in the month.

The study finds that cancer in women who took only Arimidex progressed after an average of 2.4 months, compared with 4.8 months for women taking both Arimidex and Herceptin (Kaiser Daily Women's Health Policy Report, 10/6).

"The results from the TAnDEM study show once again that Herceptin should be the backbone for all HER2-positive breast cancer patients -- it consistently benefits patients regardless of whether it is given in the early- or advanced-stage settings, or whether it is in combination with chemotherapy, hormonal therapy, or as a single agent," Eduard Holdener, global head of Roche Pharma Development, said, adding, "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" (Roche release, 10/13).

Herceptin in 2000 received approval in the European Union for use as an advanced treatment for HER2-positive breast cancer and in 2006 as a treatment for early-stage HER2-positive breast cancer, Roche said.

Approximately two-thirds of postmenopausal women who have breast cancer have hormone-sensitive cancer, and up to one-fourth also have HER2-positive cancer, according to Reuters (Reuters, 10/13).