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FDA Approves Eli Lilly and Company’s Breast Cancer Treatment
FDA based its approval on a Phase 3 trial, which found that patients who received the breast cancer treatment showed significant improvement in invasive disease-free survival.
FDA recently approved Eli Lilly and Company’s Verzenio to treat adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), early breast cancer.
The agency approved the drug combined with endocrine therapy for patients with early breast cancer at high risk of recurrence and a Ki-67 score of less than 20 percent. Ki-67 is a marker of cellular proliferation.
Verzenio is the first and only CDK4/6 inhibitor approved for this patient population.
“This new indication in HR+ HER2- early breast cancer represents another important step forward for people who are in need of new treatment options,” Jacob Van Naarden, senior vice president, CEO of Loxo Oncology at Eli Lilly and Company and president of Lilly Oncology, said in the announcement.
“We are pleased with this initial approval in the adjuvant setting and as these data continue to mature, we look forward to further opportunities to work with health authorities to expand the use of Verzenio in this setting,” Naarden continued.
FDA based its approval on the randomized, open-label Phase 3 monarchE trial, which studied Verzenio in adults with HR+ HER2-, node-positive, resected EBC with clinical and pathological features consistent with a high risk of disease recurrence.
Patients received two years of Verzenio 150 milligrams twice daily plus standard endocrine therapy or standard endocrine therapy alone in the trial.
The primary endpoint of the study was invasive disease-free survival (IDFS). Patients who received Verzenio plus endocrine therapy showed significant improvement (37 percent) in IDFS compared to those treated with endocrine therapy alone.
Researchers also conducted a pre-specified analysis of IDFS in patients with high-risk clinical and pathological factors and a Ki-67 score of less than 20 percent.
This analysis also showed a statistically significant improvement in IDFS for these patients receiving plus endocrine therapy compared to those who received endocrine therapy alone.
Notably, the number of adverse events at the time of analysis was 104 with Verzenio plus endocrine therapy compared to 158 with endocrine therapy alone.
This FDA approval follows previous approvals for Verzenio, including a 2017 approval to treat certain types of HR+ HER2- advanced or metastatic breast cancer. FDA has also expanded the use of Verzenio in all indications to include men.
“This FDA approval for Verzenio in combination with endocrine therapy in the early breast cancer setting has the potential to become a new standard of care for this population,” said Sara M. Tolaney, MD, MPH, Harvard Medical School, Dana-Farber Cancer Institute, and investigator on the monarchE study.
