FDA Approves Novartis' Kisqali to Reduce Early Breast Cancer Recurrence

Novartis has recently achieved a significant milestone with its cancer drug, Kisqali, following a new approval from the U.S. Food and Drug Administration (FDA). This approval allows the oral treatment to be used for patients with hormone receptor positive/HER-2-negative stage 2 or 3 breast cancer who are at a high risk of recurrence. This regulatory decision effectively doubles the treatable adjuvant population, now including patients whose cancer has not yet spread to their lymph nodes.

The FDA's decision was rooted in promising Phase 3 clinical trial data. The data demonstrated that when Kisqali is combined with endocrine therapy, it significantly reduces the risk of cancer recurrence by 25.1% compared to using endocrine therapy alone. This risk-reduction becomes even more significant over time, increasing to 28.5% after a three-year treatment period. These findings were recently presented at the European Society for Medical Oncology's annual meeting, underlining the effectiveness of Kisqali in prolonging the period of remission for breast cancer patients.

Dennis Slamon, a prominent cancer researcher from UCLA and the lead investigator of the Phase 3 study, highlighted the importance of this approval. He stated that the new approval allows a broader group of patients to benefit from a CDK4/6 inhibitor combined with endocrine therapy, thereby minimizing the risk of cancer recurrence more effectively.

However, the benefits of Kisqali come with some side effects. In the Phase 3 study, around 44% of patients treated with Kisqali experienced grade 3 or 4 neutropenia, a condition where the patient has lower-than-normal levels of infection-fighting white blood cells. Additionally, 8.6% of the patients reported grade 3 or 4 liver-related adverse events.

Despite these side effects, Kisqali has been making a significant impact in the market. CEO Vas Narasimhan discussed the drug's progress during the company's latest earnings call, noting that Kisqali’s global revenue for the second quarter saw a 50% rise compared to the same period in 2023. The drug has also been leading its competitors in new-to-brand prescriptions, which is a critical commercial metric indicating new patient uptake.

The FDA-approved label for Kisqali aligns well with Novartis’ growth expectations. CEO Narasimhan had previously identified Kisqali as a key part of Novartis' core portfolio, projecting that the drug could contribute to the company achieving mid-single-digit growth beyond 2027. This recent FDA nod is a major step forward in realizing that goal, expanding Kisqali's potential to help a broader range of breast cancer patients while also bolstering Novartis' market position.