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.
“Today’s approval allows us to offer treatment with a CDK4/6 inhibitor [Kisquali] 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,” says Dr. Dennis Slamon, director of clinical research at UCLA’s Jonsson Comprehensive Cancer Center in a news release.
When combined with standard hormone therapy, Kisqali has been shown to reduce the risk of breast cancer returning in patients with early-stage cancer—particularly in those whose cancer hasn’t yet spread to the lymph nodes.
In a Phase 3 trial, patients who took Kisqali saw a 25 percent reduction in recurrence risk after three years compared to hormone therapy alone. By year four, that number improved to 28.5 percent.
As many as 90 percent of breast cancer diagnoses occur at early stages (stages 1-3), and for these women, reducing the risk of recurrence is critical. Even though treatments like surgery, radiation and hormone therapy help eliminate cancer cells, there’s still a lingering chance that the disease could return.
“With this approval, we are redefining treatment options for a broader population of people impacted by breast cancer and facing the persistent risk of recurrence,” said Novartis president Victor Bultó.
With this new approval, Kisqali joins a growing number of tools designed to help survivors prevent recurrence. As more and more women are diagnosed with breast cancer, finding ways to reduce this risk is increasingly important.
