Novartis secures first-line FDA approval in breast cancer indication

pharmafile | March 14, 2017 | News story | Manufacturing and Production, Sales and Marketing |  Kisqali, Novartis, breast cancer 

The FDA has approved Kisqali (ribociclib) in combination with letrozole for the first-line treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.

The approval was based on a Phase 3 trial wherein the combination was able to show greater efficacy than letrozole alone. The primary endpoint was based on progression-free survival (PFS), and found that the combination improved survival by 44% over letrozole alone.

The study found that more than half of patients taking Kisqali plus letrozole were still alive at interim analysis. After an 11-month additional follow-up, median PFS of Kisqali plus letrozole stood at 25.3 months while letrozole alone was found to have a median PFS of 16.0 months.

Kisqali is an oral drug that is taken once-daily for three weeks. It is able to slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6. When the proteins are over-activated, this can cause cancer cells to grow and divide at increased rate. However, when using medication targeting these proteins, the rate of growth is thought to decrease.

“In the MONALEESA-2 trial, ribociclib plus letrozole reduced the risk of disease progression or death by 44 percent over letrozole alone, and more than half of patients (53%) with measurable disease taking ribociclib plus letrozole experienced a tumour burden reduction of at least 30 percent. This is a significant result for women with this serious form of breast cancer,” said Gabriel N. Hortobagyi, Professor of Medicine, Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center and MONALEESA-2 Principal Investigator. “These results affirm that combination therapy with a CDK4/6 inhibitor like ribociclib and an aromatase inhibitor should be a new standard of care for initial treatment of HR+ advanced breast cancer.”

The positive news on the approval will boost Novartis’ high hopes for Kisqali, it expects the drug to be its next blockbuster.

Ben Hargreaves