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Breakthrough therapy designation for Novartis in advanced breast cancer treatment

Published on 03/08/16 at 08:47am

Novartis has announced that the US Food and Drug Administration (FDA) has granted a breakthrough therapy designation to LEE011 (ribociclib) as a first line treatment in HR+/HER2- advanced breast cancer.

LEE011 is a selective cyclin dependent kinase (CDK4/6) inhibitor. When overactive in a cell, these proteins enable cancer cells to proliferate and grow at a faster rate. Novartis has evaluated LEE011 in a variety of late-stage trials in different breast cancer indications. In the MONALEESA-2 trial, and in combination with letrozole, LEE011 managed to significantly improve progression free survival in postmenopausal women who had received no prior therapy.

For women with advanced breast cancer, either at locally advanced (stage three) or metastatic (stage four), the prognosis is usually poor. For those suffering from metastatic breast cancer, the five year survival rate is only around 22%. Novartis indicates that this breakthrough therapy designation endorses LEE011 as having the potential to meet the unmet need for women with advanced breast cancer.

Alessandro Riva, global head at Novartis Oncology, says: “Despite advancements in treatment, an estimated 40,000 individuals in the US die each year from advanced breast cancer. The designation shows the potential of LEE011, and we look forward to close collaboration with the FDA and the advanced breast cancer community to provide a new treatment option for women living with HR+/HER2- advanced breast cancer as quickly as possible.”

This is the 11th breakthrough therapy designation granted to Novartis since the FDA initiated the program in 2013.

Sean Murray

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