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Anastrozole Receives FDA Priority Review for Early Breast Cancer Indication

Anastrozole Receives FDA Priority Review for Early Breast Cancer Indication

The US Food and Drug Administration (FDA) has granted a 6-month priority review status to the supplemental new drug application filed by the AstraZeneca corporation for the use of anastrozole (Arimidex) in the adjuvant treatment of early breast cancer in postmenopausal women. Priority review status is granted for new drugs or indications that represent a significant improvement in efficacy or safety over existing treatments.

"AstraZeneca is committed to constantly expanding the treatment options breast cancer patients have at their disposal to fight this disease," said Gerard T. Kennealey, MD, vice president of clinical research, oncology, for AstraZeneca. "The FDA’s granting of priority review status for Arimidex as an early breast cancer treatment is an important milestone in the history of breast cancer treatment."

ATAC Trial

Priority review status for anastrozole was based on data from the ATAC study (Arimidex and Tamoxifen, Alone or in Combination) conducted in more than 9,300 postmenopausal women with early breast cancer. Early results from that study showed that anastrozole reduced the risk of disease recurrence by 17% over tamoxifen as well as the risk of contralateral breast cancer by 58% over tamoxifen.

Current Indications

Anastrozole is currently approved for first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer and also for the treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Common side effects seen in clinical trials have included hot flashes, nausea, asthenia, back and bone pain, and increased cough. Joint pain and stiffness have also been reported.

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