The Food and Drug Administration (FDA) has approved Kisqali, a breast cancer drug designed to treat advanced metastatic cases, for use in patients with earlier stage breast cancer.
Novartis, the drug’s manufacturer, said that up to tens of thousands of women with early-stage breast cancer may get a new option that can help prevent their cancer from coming back.
This is the first approval for an indication specifically for breast cancer patients with multiple additional risk factors after neoadjuvant treatment,” noted Dr. Eleonora Teplinsky, head of breast and gynecologic medical oncology at Valley Health System in New Jersey, who also wasn’t involved in the study.
Depending on your risks, up to 30% of breast cancers can come back,” she explained. And the thing is, when your cancer comes back as stage four, that’s not a disease we can cure ― even though we have treatments for it. Early stage or “ally” cancer like mine just means we caught it before it turned into an aggressive terminal cancer in your organs. “People die from that cancer,” she added.
In a phase 3 clinical trial of more than 5,000 women conducted by Novartis, Kisqali lowered the risk of breast cancer recurrence when taken along with standard treatments, which typically include surgery, chemotherapy, radiation and hormone therapy. Three years after that trial ended, researchers found that taking Kisqali the breast cancer drug in addition to those usual treatments reduced a woman’s risk of developing recurring breast cancer by 25%. New analysis presented at an oncology conference in Barcelona showed that benefit increased to 28.5% risk reduction after four years.
Dr. Vandana Abramson, co-leader of the Breast Cancer Research Program at the Vanderbilt-Ingram Cancer Center in Nashville, Tennessee, said she was optimistic about Kisqali’s impact, as even a small reduction in the risk of recurrence could help patients significantly.
“We want to do everything we can to incrementally decrease the chances of this cancer coming back,” Abramson said. And while, for instance, a patient may have a 10% chance of the cancer returning, Kisqali could potentially lower that arch by such-and-such-percent-to around 7%. Understanding that if-your-cancer-comes-back numbers are becoming increasingly important.
Before the breast cancer drug approval, only one other breast cancer drug in its class, Verzenio, was approved for reducing the risk of metastatic breast cancer recurrence. But it was indicated only for patients at particularly high risk of their disease recurring. In contrast, Kisqali is expected to be available to a broader group of metastatic breast cancer patients, including those whose cancers are less aggressive at diagnosis.
