Women with early stage breast cancer may now take Kisquali, 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.

“The FDA approval of Kisqali for this early breast cancer population, including those with NO [hasn’t spread to nearby lymph nodes] disease, is a pivotal moment in improving our approach to care,” said Dr. Dennis Slamon, director of clinical/translational research at UCLA’s Jonsson Comprehensive Cancer Center and lead investigator on the company’s trial of the drug.

“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,” he added in a company news release.

What prompted the expanded approval?

In a phase 3 clinical trial involving women with earlier stage cancers, Kisqali reduced the risk of a breast cancer coming back by 25% after three years when given along with standard treatments, which can include chemotherapy, surgery and radiation followed by hormone therapy.

After four years, Kisqali reduced the risk by 28.5%, according to an updated analysis presented Monday at the European Society for Medical Oncology annual meeting in Barcelona.

“We want to do everything that we can to incrementally decrease the chances of this cancer coming back,” Dr. Vandana Abramson, co-leader of the Breast Cancer Research Program at the Vanderbilt-Ingram Cancer Center in Nashville, Tenn., told NBC News. “So if a patient was already at a potentially 10% risk of the cancer coming back, this would decrease it further, down to 7%.” 

While Verzenio, a drug in the same class, has been approved to lower the risk of early breast cancer returning, it’s only for people with a very high risk of recurrence. Kisqali will be available to a much broader group of patients, whose disease may not be as aggressive at the time of diagnosis, Novartis said. 

The expanded approval is for patients with HR-positive, HER2-negative breast cancer, the most common form of the disease. It’s for stage 2 and 3 cases, meaning the cancer hasn’t spread beyond the breast or nearby lymph nodes.

While the drug’s effects were studied for three years, research has shown that breast cancer can recur decades after diagnosis. 

“It would be nice to still see additional longer follow-up data to see if we are impacting just rates of early recurrences, or will we also have an impact on late recurrences?” Dr. Komal Jhaveri, a breast medical oncologist at Memorial Sloan Kettering Cancer Center in New York City, told NBC News.

Still, the drug will not come cheap. 

“The cost, out-of-pocket, if you’re taking it for the entire three years, would be close to $300,000-$400,000,” Abramson noted.

With the expanded approval, it’s more likely that insurance plans will offer coverage for the treatment, but that can still tax the health care system as a whole.  

“Some of the criticisms of the study have been: well, it was only a 3% benefit,” Dr. Eleonora Teplinsky, head of breast and gynecologic medical oncology at Valley Health System in New Jersey, told NBC News. “Three percent more patients benefit. What does that mean? But I think that’s then up to the patient to decide what they want to do. It’s important for them to have the option.”

More information

The American Cancer Society has more on breast cancer.

SOURE: Novartis, news release, Sept. 17, 2024; NBC News

Source: HealthDay