This Early-Stage Breast Cancer Drug Will Be Widely Available, Thanks to a Clinical Trial

(HealthDay News) — Women with early-stage breast cancer may now take Kisqali, a medication already approved for advanced disease, following the U.S. Food and Drug Administration’s expanded approval of the treatment, drug maker Novartis announced Tuesday. “The FDA approval of Kisqali for this early breast cancer population, including those with NO [hasn’t spread to nearby lymph nodes] disease, is a pivotal moment in improving our approach to care,” said Dr. Dennis Slamon, director of clinical/translational research at UCLA’s Jonsson Comprehensive Cancer Center and lead investigator on the company’s trial of the drug. “Today’s approval allows us to offer treatment with a CDK4/6 inhibitor [Kisqali] to a significantly broader group of people as a powerful tool that, combined with endocrine therapy, can help further minimize their risk of cancer returning,” he added in a company news release. What prompted the expanded approval? In a phase 3 clinical trial involving women with earlier-stage cancers, Kisqali reduced the risk of breast cancer coming back by 25 percent after three years when given along with standard treatments, which can include chemotherapy, surgery and radiation followed by hormone therapy. After four years, Kisqali reduced the risk by 28.5 percent, according to an updated analysis presented...