FDA expands use of breast cancer drug Kisqali

Women with early-stage breast cancer can now take Kisqali, a drug already approved for advanced disease, after the U.S. Food and Drug Administration (FDA) expanded approval for the treatment, pharmaceutical company Novartis announced on Tuesday.

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

“Today’s approval enables us to offer treatment with a CDK4/6 inhibitor [Kisqali] to a much broader group of people as an effective agent that, when combined with endocrine therapy, can help further reduce the risk of cancer recurrence,” he added in a company press release.

What was the reason for the extended approval?

In a Phase III clinical trial of women with early-stage cancer, Kisqali reduced the risk of breast cancer recurrence by 25% after three years when given along with standard treatments, which may include chemotherapy, surgery and radiation followed by hormone therapy.

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

“We want to do everything we can to gradually reduce the likelihood of cancer recurrence,” said Dr. Vandana Abramson, co-director of the breast cancer research program at the Vanderbilt-Ingram Cancer Center in Nashville, Tennessee, NBC News. “So if a patient already has a potential 10% risk of cancer recurring, this would further reduce that risk to 7%.”

While Verzenio, a drug in the same class, has been approved to reduce the risk of early-stage breast cancer recurrence, it is only approved for people at 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 applies to patients with HR-positive, HER2-negative breast cancer, the most common form of the disease. It applies to stage 2 and 3 cases, meaning the cancer has not spread beyond the breast or nearby lymph nodes.

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

“It would be nice to see more data from longer follow-up to see if we are only affecting the rate of early recurrence or also the rate of late recurrence?” said Dr. Komal Jhaveri, a breast cancer oncologist at Memorial Sloan Kettering Cancer Center in New York City. NBC News.

However, the drug will not be cheap.

“If you take the program for the full three years, the out-of-pocket cost would be about $300,000 to $400,000,” Abramson noted.

With expanded approval, health insurers are more likely to cover treatment, but this can still place a burden on the health care system as a whole.

“Some of the criticisms of the study were: Well, it was only a 3% benefit,” said Dr. Eleonora Teplinsky, chief of breast and gynecologic medical oncology at Valley Health System in New Jersey NBC News. “Three percent more patients benefit from it. What does that mean? But I think it's then up to the patients what they want to do. It's important that they have the opportunity.”

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