FDA Expands Kisqali Use to Early-Stage Breast Cancer Patients, Doubling Treatment Reach

The FDA has broadened the use of Kisqali, a breast cancer treatment from Novartis, making it available to patients with certain early-stage breast cancers. Previously reserved for those with metastatic disease, this new approval allows Kisqali, in combination with hormone therapy, to be used in a wider range of patients, including those in stage 2 and stage 3 breast cancer. This expansion opens the door for more women to access the drug, more than doubling the eligible patient population compared to other similar treatments.

Kisqali, also known by its scientific name ribociclib, belongs to a class of therapies called CDK4/6 inhibitors, which target proteins responsible for unchecked cancer cell growth. These inhibitors have played a vital role in managing advanced hormone receptor-positive, HER2-negative breast cancer, which is the most common subtype of the disease. With this new approval, Kisqali becomes the first drug in this class to be available for early-stage patients, including those without lymph node involvement.

This expanded approval stems from data in the Phase 3 NATALEE trial, which found that Kisqali, when paired with endocrine therapy, reduced the risk of breast cancer recurrence by 28.5% compared to endocrine therapy alone. The study, presented at a recent medical conference in Barcelona, revealed that this protective effect continued even a year after patients had stopped taking the drug, offering a long-lasting benefit.

Despite the promise of Kisqali, side effects such as low white blood cell counts and joint pain remain concerns. The treatment is designed to be taken for three years post-surgery, which contrasts with Eli Lilly’s Verzenio, another CDK4/6 inhibitor approved for certain early-stage breast cancers, which is taken for two years but can cause different side effects, including diarrhea.

The approval of Kisqali for early-stage breast cancer highlights the growing role of targeted therapies in treatment, providing more tailored options for patients. However, early detection remains critical, as many breast cancers can still be effectively treated without the need for advanced therapies or chemotherapy, particularly when caught at earlier stages.