Eli Lilly’s Verzenio, a CDK4/6 inhibitor, has received FDA approvals that significantly expand its use in treating early-stage breast cancer. Previously, Verzenio was approved for adjuvant (pre-surgery) treatment alongside endocrine therapy for HR+/HER2- early breast cancer patients who tested positive for the Ki-67 biomarker. The new approval removes the necessity for Ki-67 testing, allowing the drug to be prescribed based on other clinical factors such as tumor size, grade, and lymph node involvement.
This decision is based on the monarchE study results, which demonstrated that adding Verzenio to adjuvant endocrine therapy reduced the risk of recurrence by 35% compared to adjuvant endocrine therapy alone.
Additionally, the FDA has lifted the restriction limiting Verzenio's use in advanced breast cancer to post-menopausal women, making it available to all adults, including pre- and peri-menopausal women, who represent about 17% of the patient population.
These approvals are crucial for Verzenio's growth, as it competes with Pfizer’s Ibrance and Novartis’ Kisqali in the CDK4/6 inhibitor market. Verzenio remains the only drug in its class approved for adjuvant use in early breast cancer, contributing to its sales growth of 84% to nearly $2.5 billion last year.
Lilly emphasizes the impact of the adjuvant approval on both the drug's market position and patient care. "This expanded approval will allow us to bring Verzenio to many more women and men with HR+, HER2-, high-risk early breast cancer in the curative setting – before patients experience recurrence, potentially to incurable metastatic disease," said Jacob Van Naarden, chief executive of Lilly's Loxo@Lilly subsidiary.
