FDA gives priority review status to Novartis’ breast cancer drug

The drug is intended to be used in combination with letrozole as a first-line treatment of postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.

Ribociclib claimed to be a selective cyclin dependent kinase inhibitor which will slow the progress of cancer by inhibiting two proteins called cyclin dependent kinase 4 and 6 (CDK4/6).

Apart from the FDA Priority Review, LEE011 plus letrozole has also been accepted for review by the European Medicines Agency (EMA) for its marketing authorization application.

Novartis Oncology CEO Bruno Strigini said: “These regulatory milestones, along with the FDA Breakthrough Therapy designation granted in August, underscore the need for new treatment options for women living with HR+/HER2- advanced breast cancer.

"Priority Review allows a shorter review period compared with FDA standard review in the US, helping us to potentially bring LEE011 plus letrozole to patients more quickly. We also are working diligently with the EMA and other Health Authorities to bring this treatment to patients around the world as fast as possible."

According to Novartis, its new drug application to the FDA was based on a comprehensive clinical package which included the drug’s Phase III MONALEESA-2 trial results.

The trial proved LEE011 plus letrozole to cut down the risk of progression or death by 44% compared to using only letrozole while extending progression-free survival (PFS) across all patient subgroups by a significant margin.

Developed by Novartis Institutes for BioMedical Research (NIBR) in collaboration with Astex Pharmaceuticals, ribociclib is a selective cyclin dependent kinase inhibitor (CDK4/6) claimed to slow down the progression of cancer.

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