The Food and Drug Administration has expanded the approval of Kisqali, a drug for metastatic breast cancer, to also treat patients with earlier stages of the disease, Pharmacist Novartis said on Tuesday.

The approval means that tens of thousands of women diagnosed with early-stage breast cancer will have access to a medication that can help prevent their cancer from returning.

“Depending on your risks and everything, up to 30% of breast cancers can come back,” said Dr. Eleonora Teplinsky, head of breast and gynecologic medical oncology at the Valley Health System in New Jersey. “If it comes back as the fourth stage, then while we have treatment, it is not curable. People die from that cancer.”

In a phase 3 clinical trial by drugmaker NovartisKisqali reduced the risk of the patient’s breast cancer returning by 25% after three years, when it is given in addition to standard treatments, which may include chemotherapy, surgery and radiation followed by hormonal therapy.

After four years, Kisqali reduced the risk by 28.5%, according to a updated analysis presented on Monday at the European Society of Medical Oncology conference in Barcelona.

“We want to do everything we can to gradually decrease the chances of this cancer coming back,” said Dr. Vandana Abramson, who is the co-leader. of the Breast Cancer Research Program at the Vanderbilt-Ingram Cancer Center in Nashville, Tennessee. “So, if a patient was already at a potential risk of 10% of the cancer coming back, this would decrease even more, up to 7%.”

Until now, only Verzenio, another drug in the same class, has been approved to reduce the risk of early breast cancer returning in a patient, but it was only for people with a very high risk of relapse. Kisqali, on the other hand, will be available to a much wider group of patients, whose disease may not be so aggressive at the time of diagnosis.

It might also cause fewer side effects, Teplinksy said.

Extended approval is for patients with HR-positive, HER2-negative breast cancer, the most common form of the disease. It is for stage two and three diagnoses, which means the cancer has not spread outside the breast or nearby lymph nodes.

It comes as breast cancer rates are on the rise in younger women: From 2000 to 2019, breast cancer rates in women aged 20 to 49 increased by 15.6% according to a study published earlier this year in JAMA Network Open.

Nikki Odum, 42, was diagnosed with breast cancer when she was 36.

“The first thing I thought was, ‘I’m not ready to die, so what am I going to do?'” said Odum, of Smyrna, Tennessee.

After having a double mastectomy, chemotherapy and radiation, her doctor, Denise Yardley, asked if she wanted to join the clinical trial for Kisqali. “It was a no brainer for me. I was like, ‘The game, let’s do it,'” Odum said.

Yardley, the associate director of breast cancer research at the Sarah Cannon Research Institute in Nashville, was one of the clinical trial investigators. Patients in the trial either took standard hormone therapy or took Kisqali plus hormone therapy for three years after completing their main treatment regimen.

Throughout the trial, patients were monitored for side effects, such as low white blood cell counts and elevated liver enzymes, Yardley said.

If someone has experienced a side effect, “typically we have a drug, take care of the symptom and start again. If it occurs again, then we will make a reduction in the dose,” he said. About 20% of participants who received Kisqali dropped out of the trial for these reasons.

Odum was part of the group that took Kisqali plus hormone therapy. At some point, he developed a rash on his body and had to stop the treatment.

Even so, he said “for me, Kisqali was something that was a bonus. It’s something that I know in my heart helped me”.

The effects of the drug were studied for three years in the process, however, breast cancer can relapse decades after diagnosis.

“It would be nice to also see additional longer follow-up data to see if we only have an impact on early relapse rates, or do we also have an impact on late relapses?” said Dr. Komal Jhaveri, a breast medical oncologist at Memorial Sloan Kettering Cancer Center in New York.

Abramson, of the Vanderbilt-Ingram Cancer Center, noted that the drug is not cheap.

“The cost, out of pocket, if you take it for all three years, would be close to $300,000-$400,000,” he said.

With the extended approval, it is more likely that insurance plans will offer coverage for the treatment, so that patients do not have to pay the cost of the bag, but that can impose costs on the health system in general .

“Some of the criticisms of the study have been: well, it was only a 3% benefit,” Teplinsky said. “Three percent more patients benefit. What does that mean? But I think it’s up to the patient to decide what they want to do. It’s important for them to have the option.”

For Odum, the peace of mind the medication afforded him was worth it.

“You still have to deal with the fact every day that you have breast cancer,” she said. “I know I’m doing everything I can to keep living.”