September 18, 2024 – People with a general type of early-stage breast cancer can now take one other drug called Kisqali, which has been shown to significantly reduce the chance of the cancer recurring, in response to the FDA announced Tuesday.
Kisqali is already approved for patients with metastatic breast cancer. The latest approval implies that patients with HR-positive, HER2-negative breast cancer in stage II or III and a high risk of reoccurrence may also use the treatment. Kisqali is taken along with a hormone therapy called an aromatase inhibitor.
In a Press release from the pharmaceutical company Novartis, Dennis J. Slamon, MD, who Research study which led to FDA approval, called it “a pivotal moment in improving our approach to treatment.” Slamon is director of clinical translational research on the UCLA Jonsson Comprehensive Cancer Center in Los Angeles.
The FDA recommends taking Kisqali for 3 years. The drug is available in tablet form and is taken each day for 21 days, followed by a seven-day break in treatment.
In a clinical trial, 90% of people that took Kisqali with an aromatase inhibitor for 3 years remained cancer-free, compared with 87% who took an aromatase inhibitor alone. The results corresponded to a 25% reduced risk of reoccurrence. The risk reduction was independent of whether the cancer had previously spread to the lymph nodes.
Kisqali works by interfering with substances that play a key role in the expansion and survival of cancer cells, and it could possibly also affect healthy cells.
Some people within the clinical trial had low levels of white blood cells, which may result in risks of infection, liver problems, or a certain kind of irregular heart rhythm. Side effects of Kisqali include headache, nausea, and tiredness.
“Treatment for breast cancer can take a huge toll on your physical and mental health, and you may be concerned about the risk of your cancer coming back,” said Valarie Worthy, a registered nurse with a Master of Science in nursing, in response to the Novartis press release. Worthy is co-founder and vice chairman of outreach and engagement for Touch, the Black Breast Cancer Alliance. “This risk is different for everyone and depends on many factors, but it should not be underestimated.”