The U.S. Food and Drug Administration has extended the approval of Kisqali, a drug previously used for advanced breast cancer, to now include women with early-stage breast cancer, as announced by Novartis.
Dr. Dennis Slamon, a lead researcher at UCLA, emphasized the significance of this approval, which enables a wider group of patients, even those whose cancer hasn’t spread to lymph nodes, to benefit from Kisqali, used in combination with endocrine therapy to reduce the risk of cancer recurrence.
The expanded approval follows a phase 3 clinical trial showing that Kisqali, when added to standard treatments like chemotherapy, surgery, radiation, and hormone therapy, lowered the risk of breast cancer returning by 25% after three years, and by 28.5% after four years, according to updated findings presented at a European medical conference.
Dr. Vandana Abramson from Vanderbilt-Ingram Cancer Center explained that the drug offers an incremental reduction in the risk of recurrence, which can make a significant difference for patients. While another drug, Verzenio, has already been approved for early breast cancer, it’s limited to patients with a high risk of recurrence, whereas Kisqali is available to a broader group with less aggressive disease.
Kisqali’s expanded use is for patients with HR-positive, HER2-negative stage 2 or 3 breast cancer, meaning the cancer hasn’t spread beyond the breast or nearby lymph nodes. However, long-term data on its effectiveness, particularly in preventing late recurrences, is still being awaited.
Despite the promise of the drug, it comes at a high cost—up to $300,000 to $400,000 over three years. Although insurance coverage is expected to improve with the expanded approval, the overall cost burden on the healthcare system remains a concern.
While some experts, like Dr. Eleonora Teplinsky, have pointed out that the benefit may seem modest (about 3%), she stressed that the decision ultimately rests with patients, as having the option to reduce the risk, however small, is valuable.