FDA approves Novartis drug as first-line treatment for breast cancer

A sign marks a building on Novartis' campus in Cambridge, Massachusetts, U.S., February 28, 2017. REUTERS/Brian Snyder

(Reuters) - Novartis AG said on Monday that the U.S. Food and Drug Administration had approved the company’s experimental drug, kisqali, as a first-line treatment for a type of breast cancer in postmenopausal women, in combination with another breast cancer drug.

The approval is based on a late-stage data, which showed that kisqali, along with letrozole, met the main goal of progression-free survival (PFS) at an interim analysis compared to patients treated with letrozole alone.

More than half of patients taking kisqali plus letrozole remained alive and progression-free at the time of the interim analysis, the company said. (

Kisqali, an oral drug, helps in slowing down the progression of cancer by preventing two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). These proteins when over-activated can enable cancer cells to grow and divide too quickly.

Kisqali, by targeting CDK4/6, helps in ensuring that cancer cells do not continue to replicate uncontrollably.

Breast cancer is the second most common cancer in American women. The American Cancer Society estimates that more than 250,000 women will be diagnosed with invasive breast cancer in 2017.

Reporting by Dipika Jain in Bengaluru; Editing by Maju Samuel