Sign Up

Novartis Wins FDA Approval of Kisqali for Early Breast Cancer

Novartis (NYSE: NVS) announced that the FDA has approved breast cancer drug Kisqali (ribociclib) for a broader population.

The regulatory body approved Kisqali in combination with an aromatase inhibitor for the adjuvant treatment of people with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) stage II and III early breast cancer (EBC) at high risk of recurrence, including those with node-negative (N0) disease.

Kisqali is a selective cyclin-dependent kinase inhibitor, a class of drugs that helps slow the progression of cancer by inhibiting two proteins — cyclin-dependent kinase 4 and 6 (CDK4/6).

The broad indication in HR+/HER2- stage II and III EBC at high risk of recurrence approximately doubles the population eligible for CDK4/6 inhibitor adjuvant therapy.

Year to date, shares of Novartis have risen 14.6% compared with the industry's growth of 24.1%.

Image Source: Zacks Investment Research

Broader Label for NVS' Kisqali

The FDA approval is based on strong results from the late-stage NATALEE trial. The results showed a significant and clinically meaningful 25.1% reduction in risk of disease recurrence in a broad ...