Swiss drugmaker Roche said today it was seeking approval from European authorities for the use of its breast cancer drug Herceptin in post-surgery therapy for women with early-stage cancer.
Roche said it had submitted a marketing authorisation application to the European Medicines Agency for Herceptin as adjuvant treatment for early-stage HER2-positive breast cancer.
Herceptin is already under licence in Europe and in the United States as treatment for metastatic advanced cancer. The new licence, if granted, would extend the use of the drug to early stage cancer.
The European request is based on data from an international study showing that patients treated with Herceptin experienced statistically significant improvements in disease-free survival compared to patients who did not receive it.
"Results from four large trials with nearly 12,000 patients analysed from around the globe provide consistent evidence that Herceptin reduces the risk of cancer coming back by about half, providing the best chance of long-term survival to women with this aggressive form of early-stage breast cancer," Roche said.
Earlier in the week, Genentech, majority-owned by Roche, said it had requested a priority review designation from the US Food and Drug Administration for the use of Herceptin for women with early-stage cancer who have undergone surgery.