The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Swiss-based healthcare company Novartis’ LEE011 (ribociclib) in combination with letrozole for the treatment of breast cancer.

LEE011 is a selective cyclin dependent kinase (CDK4/6) inhibitor that can be used for the treatment of hormone receptor positive, human epidermal growth factor receptor II-negative (HR+ / HER2-) advanced or metastatic breast cancer.

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Metastatic breast cancer is the most serious form of the disease and occurs when it has spread to other parts of the body, including the brain, bones or liver.

Advanced breast cancer is a combination of metastatic breast cancer (stage IV) and locally advanced breast cancer (stage III).

"Despite advancements in treatment, an estimated 40,000 individuals in the US die each year from advanced breast cancer."

Novartis oncology development and medical affairs global head Dr Alessandro Riva said: “Despite advancements in treatment, an estimated 40,000 individuals in the US die each year from advanced breast cancer.

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“This 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.”

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LEE011 has received FDA Breakthrough Therapy designation based on positive results of its Phase III MONALEESA-II trial, in combination with letrozole in postmenopausal women who received no prior therapy for their advanced breast cancer.

Since the FDA initiated the programme in 2013, the current Breakthrough Therapy designation is the 11th designation granted by the US agency to Novartis.

Image: Micrograph showing a lymph node invaded by ductal breast carcinoma, with extension of the tumour beyond the lymph node. Photo: courtesy of Nephron.