FDA Grants Breakthrough Designation for Novartis Breast Cancer Treatment

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

LEE011 is a selective cyclin dependent kinase (CDK4/6) inhibitor. When overactive in a cell, the proteins enable cancer cells to proliferate and grow at an increased 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 was found 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 or metastatic, the prognosis is quite often poor. For those suffering from metastatic breast cancer, the five-year survival rate is around 22%. Novartis indicates that the breakthrough therapy designation endorses LEE011 as having potential to meet the 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 designation marks the 11th breakthrough therapy designation granted to Novartis since the FDA initiated the program back in 2013.


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