Novartis was already riding a wave of momentum with Kisqali, and now it has a new FDA nod to break into the early breast cancer market.
The FDA approved the oral treatment Tuesday for patients with hormone receptor positive/HER-2-negative stage 2 or 3 breast cancer who are at high risk of recurrence. Novartis said that the green light roughly doubles the treatable adjuvant population and includes patients whose cancer has not yet spread to their lymph nodes.
The regulatory decision was based on Phase 3 data showing that when combined with endocrine therapy — another kind of breast cancer treatment — Kisqali reduced the risk of recurrence by 25.1% compared to endocrine therapy alone. That risk-reduction improved with time, growing to 28.5% following the three-year treatment period, according to new data recently presented at the European Society for Medical Oncology annual meeting.
“Today’s approval allows us to offer treatment with a CDK4/6 inhibitor to a significantly broader group of people as a powerful tool that, combined with endocrine therapy, can help further minimize their risk of cancer returning,” Dennis Slamon, a UCLA cancer researcher and lead investigator of the Phase 3 study, said in a statement.
The recurrence risk reduction is not without side effects. About 44% of patients given Kisqali in the Phase 3 study reported grade 3 or 4 cases of neutropenia, where patients had lower-than-normal levels of infection-fighting white blood cells. Another 8.6% of treated patients had grade 3 or 4 liver-related adverse events.
CEO Vas Narasimhan touted Kisqali’s progress on the company’s most recent earnings call. Kisqali’s second-quarter global revenue jumped 50% compared to the second quarter of 2023. The drug led its competitors in new-to-brand prescriptions, a key commercial metric tracking new patient uptake.
The label approved by the FDA is in line with Novartis’ optimistic expectations. Narasimhan previously included Kisqali in Novartis’ core portfolio that could help the company reach mid-single-digit growth beyond 2027.