Novartis Pressures Lilly with Broad FDA Nod for Kisqali in Early Breast Cancer

Novartis has made a significant stride in the treatment of early breast cancer with the FDA's recent approval of Kisqali for adjuvant use. This greenlight introduces a competitive landscape between Novartis and Eli Lilly in the realm of early breast cancer treatments. The FDA approved Kisqali, in combination with an aromatase inhibitor, for HR-positive, HER2-negative stage 2 and 3 breast cancer patients at high risk of recurrence post-surgery. This new label differentiates Kisqali from Lilly’s Verzenio by including patients without cancer cells in their lymph nodes, a group Verzenio's approval does not cover.

This broader indication for Kisqali nearly doubles the eligible patient population for postsurgical adjuvant therapy within the CDK4/6 inhibitor category, according to Novartis. The company had previously projected that this inclusive label could result in over $3 billion in additional annual peak sales, pushing Kisqali’s total peak sales potential to $7 billion. Kisqali is already used to treat metastatic HR+/HER2- breast cancer, and its sales surged by approximately 48% year over year in the first half of 2024, reaching $1.34 billion. Similarly, Lilly’s Verzenio saw its sales increase by 42% in the same period, reaching $2.38 billion.

The FDA's latest approval of Kisqali is underpinned by data from the phase 3 NATALEE trial, which demonstrated that adding Kisqali to endocrine therapy reduced the risk of disease recurrence or death by 25.1% compared to endocrine therapy alone in HR+/HER2- stage 2 and 3 early breast cancer. An exploratory four-year analysis presented at the European Society for Medical Oncology annual meeting revealed that Kisqali’s invasive disease-free survival benefit improved to 28.5% with extended follow-up. This data, though not included in the newly approved label, highlighted similar benefits across various patient subgroups, including those divided by disease stage and nodal involvement.

In patients without nodal involvement, 92.1% of those treated with Kisqali remained alive and disease-free at four years, compared to 87% in the control group. This 5.1% absolute improvement reflected an increase from 2.6% at the three-year mark. Novartis’ chief medical officer, Shreeram Aradhye, M.D., noted that the deepening treatment effect was observed even after patients had stopped taking Kisqali, making the data particularly compelling.

In the adjuvant setting, Kisqali is administered at a lower dose than in advanced disease, and the treatment duration is up to three years, compared to Verzenio’s two-year regimen. Novartis believes the extended treatment period could enhance long-term efficacy. The NATALEE trial showed that 62.8% of patients completed the full three-year regimen, while 37.2% discontinued early, primarily due to adverse events, with liver enzyme elevations being a significant factor. However, Novartis suggested that real-world dose adjustments and other measures might help maintain patient adherence to the treatment.

Aradhye emphasized Kisqali’s established presence as the most-used CDK4/6 inhibitor in the metastatic setting and its consistent benefits across early-stage cancer subgroups could further drive its adoption.