If approved for this new indication, the company says Femara will become the only breast cancer treatment approved in the US to significantly reduce the risk of recurrence for both the adjuvant setting and in extended adjuvant treatment following standard tamoxifen therapy.
The FDA grants priority review to products that could potentially offer a significant improvement compared to marketed products in the treatment, diagnosis or prevention of a disease. Novartis asked for consideration for priority review based on enhanced efficacy in high risk subgroups for which existing therapies have not demonstrated benefit. Specifically, Femara showed significantly improved efficacy compared with tamoxifen in women with node-positive disease and those who received chemotherapy treatment. Femara also demonstrated a significantly reduced risk of distant metastases compared with tamoxifen.
“This priority review acknowledges the potential for Femara to represent a significant advance in treating postmenopausal women with early breast cancer immediately following surgery,” said Dr Diane Young, vice president, global head, Clinical Development, Novartis Oncology.