"The groundwork of all happiness is health." - Leigh Hunt

New treatment for early breast cancer receives FDA approval

September 18, 2024 – People with a general type Patients with early-stage breast cancer can now take one other drug called Kisqali, which has been shown to significantly reduce the chance of cancer reoccurrence, the FDA said announced Tuesday.

Kisqali is already approved for individuals with metastatic breast cancer. The recent approval means individuals with HR-positive, HER2-negative stage II or III breast cancer and a high risk of reoccurrence may also use the treatment. Kisqali is taken with a hormone therapy called aromatase inhibitors.

In one Press release from the drug manufacturer Novartis, Dr. Dennis J. Slamon, who led the study Research study that led to FDA approval, called it “a pivotal moment in improving our approach to care.” 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 obtainable in tablet form and is taken every day for 21 consecutive days, followed by a 7-day break from treatment.

In a clinical trial, 90% of people that took Kisqali with an aromatase inhibitor for 3 years remained cancer-free, in comparison with 87% who took an aromatase inhibitor alone. The results corresponded to a 25% reduced risk of reoccurrence. The risk reduction was the identical no matter whether the cancer had previously spread to the lymph nodes.

Kisqali works by disrupting substances that play a key role in the expansion and survival of cancer cells, and it can also affect healthy cells.

Some people within the clinical trial had low levels of white blood cells, which might result in risks of infection, liver problems or a certain form of irregular heart rhythm. Side effects of Kisqali include headache, nausea, and fatigue.

“Breast cancer treatment can affect your physical and mental health, and you may be worried about the risk of your cancer coming back,” said Valarie Worthy, a registered nurse with a Master of Science in nursing, in keeping with Novartis News release. Worthy is co-founder and vice chairman of community outreach and engagement at Touch, the Black Breast Cancer Alliance. “This risk is different for everyone and depends on many factors, but should not be underestimated.”