Breast cancer drug Kisqali receives FDA approval to prevent cancer relapse

The US Food and Drug Administration (FDA) has approved Kisqali for the treatment of metastatic breast cancer. The drug has been shown to reduce the risk of the cancer recurring by 25 percent.

The approval will give women diagnosed with early-stage breast cancer access to a drug designed to help prevent cancer from recurring.

A Phase III study showed “a significant and clinically meaningful risk reduction of 25.1 percent,” Novartis said in a statement.

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Dr. Dennis J. Slamon, one of the study's principal investigators, said, “The FDA approval of Kisqali for this group of patients with early breast cancer … is a pivotal moment in improving our treatment approach.”

According to Novartis, about 90 percent of breast cancer cases in the United States are diagnosed at an early stage.

According to Novartis, an analysis of the drug presented ahead of the European Society of Medical Oncology conference in Barcelona found that Kisqali reduced the risk of relapse by 28.5 percent after four years.

Drug manufacturers pointed out that breast cancer treatment is likely to impose severe psychological and physical stress on patients.