Approval sought for Femara in early post-surgery use

November 05, 2017

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.

In looking at studies on the use of supplements for menopause, Warren reports that the seven clinical trials using black cohosh were largely flawed but might suggest some effectiveness. However, little evidence exists for beneficial effects of red clover, and no benefit was reported for ginseng, evening primrose oil or dong quai. In the 16 studies that looked at soy supplements, twice as many studies reported no effect as those that reported a beneficial effect, and although kava kava has been reported to have some benefit, reports of serious side effects have led to it being banned for sale in the United States and elsewhere.

For premenstrual syndrome, several studies found some benefit in about half the women studied for evening primrose oil, but two of the best designed studies found no effect; ginkgo biloba extract was found to have no effect, while a beneficial response from chaste tree berry extracts was found in about half the women studied. For menstrual pain, two clinical trials have examined the Japanese herbal preparations toki-shakuyakusan and toki-shakuyakusan with shakuyaku-kanzoto; neither found a beneficial effect.

"Some herbal medicines show promise for the treatment of problems with menstruation and menopause and other conditions that affect women," said Warren. "It is unfortunate that their quality and safety are not better controlled. Such an environment has set up a situation where there are potentially many accidents waiting to happen."

However, he said, if women choose to use herbal medicines, they should do so cautiously because the quality of these medicines varies, and the safety, especially with long-term use, is uncertain. He said that women should choose only high-quality products from reputable sources and to be sure to inform their health-care providers about their herbal medication use, because many herbal supplements can interact with other treatments.