Approval sought for Femara in early post-surgery use

Jul 12 2005

Approval is being sought in the U.S. and Europe, by Swiss drug maker Novartis, for its breast-cancer drug Femara to be used immediately after surgery to help older women fight tumours.

The approval, if granted, would mean that the drug could be available for far more women.

Femara already has approval for use in post-menopausal women who have completed a 5-year course of the post-surgery treatment tamoxifen, which is the current standard treatment, and also for women whose breast cancer has spread to other parts of the body.

Femara is the second drug, in a new class of hormone-based breast-cancer treatments, called aromatase inhibitors, to have clearly demonstrated an advantage over tamoxifen in trials.

AstraZeneca's rival product is called Arimidex.

The application for approval is based on a recent study, which showed that Femara reduced the risk of the cancer recurring by 19 percent more than tamoxifen, which is made by AstraZeneca under the brand name Nolvadex.

The trial also showed that Femara reduced the risk that the cancer would spread by 27 percent against tamoxifen.

Novartis says that finding distinguishes the drug from its rival Arimidex.

According to Novartis once approved, Femara will become the only breast-cancer treatment available which has been shown to reduce the risk of recurrence in women who have had an operation, as well as those who have had an operation and used tamoxifen.

Although aromatase inhibitors have been shown to have an advantage over current treatments, they have yet to show that they help patients live longer, and clinical trials involving Femara continue.

These drugs can only be used in women after the menopause or those whose cancer is "estrogen receptor positive".

Though Femara did not cause the side effects associated with tamoxifen, such as hot flashes or endometrial cancer, there was apparently an increased risk of bone fracture and brittle-bone disease.

Novartis expects the first approvals for the extended indication could be in late 2005 with the majority in 2006.