The U.S. FDA has approved expanded use of Novartis’ blockbuster breast cancer drug, Kisqali, to reduce risk of recurrence in people with HR+/HER2- early breast cancer — doubling the population eligible for the CDK4/6 inhibitor adjuvant therapy.
Specifically, Kisqali won the expanded nod for use in combination with an aromatase inhibitor (AI) for the adjuvant treatment of people with HR+/HER2- stage 2 and 3 early breast cancer at high risk of recurrence, including those with node-negative disease. The approval is based on results from the pivotal phase 3 NATALEE trial, which showed Kisqali significantly reduced the risk of recurrence by 25% vs. endocrine therapy alone.
For early breast cancer, Kisqali is a once-daily oral dose of 400 mg taken for three weeks, followed by one week off treatment, in combination with four weeks of any AI. Patients should take the therapy for three years.
Kisqali was first approved in 2017 for the treatment of postmenopausal women with HR+/HER2- advanced or metastatic breast cancer. The drug brought Novartis over $2 billion in sales last year.
Regulatory reviews for Kisqali as an early breast cancer treatment are currently ongoing worldwide, including in the EU and China.