FDA Grants NDA Approval and Priority Review for LEE011

The FDA has accepted Novartis' New Drug Application (NDA) and granted Priority Review for LEE011 (ribociclib). LEE011 is designed 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 in combination with letrozole.

LEE011 is a selective cyclin-dependent kinase inhibitor. It helps slow the progression of cancer by inhibiting 2 proteins, the cyclin-dependent kinase 4 and 6. When these proteins are over-activated in a cell, cancer cells can grow and divide quickly.

In terms of the toxicity and adverse effects of CDK4/6 inhibitors such as LEE011, researchers believe that there is a possible risk of infectious complications related to hematologic side effects. However, they note that more monitoring and research needs to be conducted.

The FDA based its NDA approval of LEE011 on data from the phase 3 MONALEESA-2 trial. In the trial, LEE011, in combination with letrozole, showed that it could reduce the risk of progression or death in patients by 44% compared to letrozole alone.

"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," said Bruno Strigini, CEO of Novartis Oncology, in a press release. "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.”