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FDA Considers Expanding Femara

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Breast cancer drug, Femara, was submitted for additional regulatory approval by the US Food and Drug Administration today from Swiss pharmaceutical company Novartis. Femara presents the hope of post-surgery medication that helps older women fight tumors.

FDA Considers Expanding Femara

Current regulations allow for Femara to be used in women whose cancer has spread to other parts of the body and in post-menopausal women after they have completed 5 years of treatment with tamoxifen. Approval would allow use immediately after breast cancer surgery.

Femara belongs to a family of drugs known as aromatase inhibitors, which are hormone-based breast-cancer treatments. This drug and its rival, AstraZeneca’s Arimidex, have shown better performance in trials than tamoxifen.

A recent study showed that Femara outperformed AstraZeneca’s tamoxifen by dropping cancer relapse rates an additional 19%. Femara also reduced the risk of cancer spreading to other parts of the body by 27%.

FDA Considers Expanding Femara

If the FDA approves the drug, it will become the only available treatment that has been shown to both reduce recurrence rates and spreading after surgery. Novartis says Femara has an advantage over Arimidex because of the reduced risk of cancer spreading.

Only effective after menopause or in women with “estrogen receptor positive” cancer, Femara is not associated with the same side effects as tamoxifen, marketed as Nolvadex, which include hot flashes and endometrial cancer. However, Femara does run an increased risk of bone fracture and brittle-bone disease.

Financial analysts predict that the approval of expanding the use of the drug could raise sales from last year’s $386 million to a potential in the billions of dollars.

FDA Considers Expanding Femara
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