The US 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, Novartis said.

According to experts, the approval would mean that millions of women diagnosed with early-stage breast cancer will now have access to a medication that helps prevent their cancer from coming back. “Depending on your risks and everything, up to 30 per cent of breast cancers can come back,” Dr. Eleonora Teplinsky, head of breast and gynecologic medical oncology at Valley Health System in New Jersey told NBC Health News. “If it comes back as stage four, then while we have treatment, it’s not curable. People die from that cancer.”

According to the drugmaker, in the phase three clinical trial Kisqali – an HR+ and HR2 drug, was able to reduce the risk of a patient’s breast cancer coming back by 25 per cent after three years when given in addition to other standard treatments like chemotherapy, surgery and radiation followed by hormone therapy.

In an update provided earlier this week at the European Society for Medical Oncology conference in Barcelona, Novartis said Kisqali has reduced the risk by 28.5 per cent after four years. “We want to do everything that we can to incrementally 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 potentially 10 per cent risk of cancer coming back, this would decrease it further, down to 7 per cent.”

Till now, only Verzenio - another drug in the same class, was approved to reduce the risk of a patient’s early breast cancer returning, but it was only for people with a very high risk of recurrence. Kisqali, on the other hand, will be available to a much broader group of patients, whose disease may not be as aggressive at the time of diagnosis.

According to researchers, it also causes fewer side effects.

The expanded approval is for patients with HR-positive, and HER2-negative breast cancer – the most common form of the deadly disease. It is for stage two and three diagnoses, meaning the cancer has not spread beyond the breast or nearby lymph nodes.

According to doctors, breast cancer, which is usually detected in older women, rates are significantly increasing in younger ones as well. Statistics from a study published in the JAMA Network Open say, from 2000 to 2019, rates of breast cancer in women ages 20-49 increased by 15.6 per cent.

The cost, out-of-pocket, three-year dose of Kisqali will be close to $300,000-$400,000. However, with the expanded approval, scientists say it is more likely that insurance plans will offer coverage for the treatment, but that can still tax the healthcare system as a whole.

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