The FDA’s approval of Kisqali in combination with an aromatase inhibitor allows Novartis to target patients with earlier breast cancer who are at risk of recurrence.
The FDA on Tuesday approved the expansion of Novartis’ Kisqali into earlier stages of breast cancer, allowing its use in patients with stage II or III early disease who are HR-positive/HER2-negative and are at elevated risk of recurrence.
According to the pharma, this broader indication “approximately doubles” the patient population eligible for treatment, which now includes those whose cancers have yet to involve the lymph nodes. Tuesday’s label expansion covers the use of Kisqali with an aromatase inhibitor for the adjuvant treatment of breast cancer patients.
“With this approval, we are redefining treatment options” for more breast cancer patients who are at “persistent risk” of recurrence, Victor Bultó, U.S. president of Novartis, said in a statement. The majority of breast cancers—around 90%, according to the pharma—are caught early, typically from stages I to III, and are treated with curative intent. Still, the disease threatens to recur in a more aggressive form in many patients, especially those who are HR-positive/HER2-negative.
“We continue to transform cancer care with Kisqali, building on its established profile in the metastatic setting and now helping a wide range of people as they strive to stay cancer-free following an early-stage diagnosis,” Bultó said.
Kisqali’s broader expansion was backed by data from the Phase III NATALEE trial. In March 2023, Novartis posted topline data from the study, touting a significant improvement in disease-free survival versus standard adjuvant endocrine therapy alone. The pharma did not present specific data at the time but announced that an independent data monitoring committee had recommended to end the study early.
On Monday, a day before the FDA cleared Kisqali’s label expansion, Novartis posted updated data from NATALEE, demonstrating that the regimen “shows a deepening benefit” after the study’s three-year treatment period. At the long-term follow-up, Kisqali plus endocrine therapy reduced the risk of recurrence by 28.5% versus endocrine therapy alone. Distant disease-free survival was also significant in favor of Kisqali, while overall survival showed a trend toward improvement.
Designed to be taken orally, Kisqali is a small-molecule blocker of the CDK4 and CDK6 kinases, which are central to signaling pathways that lead to cell cycle progression and proliferation. According to its label, Kisqali’s mechanism of action helps it reduce tumor volume and block the further growth of tumors. The drug was first approved by the FDA in March 2017 for HR-positive/HER2-negative metastatic breast cancer, and its indication was expanded in July 2018 to include advanced disease.
