FDA Clears Lilly’s Verenzio for Early Breast Cancer

The FDA has approved Eli Lilly and Company’s Verzenio (abemaciclib), the first and only CDK4/6 inhibitor approved for patients with specific types of breast cancer.

Verzenio, in combination with endocrine therapy (tamoxifen or an aromatase inhibitor), is indicated for the adjuvant treatment of patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer at high risk of recurrence, and at high risk of recurrence a Ki-67 score of ≥20%, Lilly said in a news release.

Additionally, the FDA approved Agilent Technologies’ Ki-67 IHC MIB-1 pharmDx (Dako Omnis) as an aid in identifying patients with early breast cancer at high risk of disease recurrence. This is the first IHC assay measuring Ki-67 expression to receive FDA approval in the context of treatment with Verzenio and was developed in collaboration with Lilly.

Quest Diagnostics is the first laboratory to have validated the test in conjunction with Agilent

Verzenio is already approved for certain types of HR+, HER2-advanced, or metastatic breast cancer. “Concurrent with this approval, the FDA has expanded the use of Verzenio in all indications, when given in combination with endocrine therapy, to include men,” Lilly said.

The approval is based on results from a phase 3 open-label, two cohort, multicenter study in adult women and men with HR+ HER2-, node-positive, resected EBC with clinical and pathological features consistent with a high risk of disease recurrence.

There was a statistically significant improvement in invasive disease-free survival (IDFS) for the pre-specified subgroup of patients receiving Verzenio plus endocrine therapy versus those who received endocrine therapy alone.

In an analysis with additional follow-up, Verzenio given in combination with endocrine therapy continued to demonstrate a clinically meaningful benefit, Lilly found. There was a 37% decrease in the risk of breast cancer recurrence or death compared with standard adjuvant endocrine alone for patients with high risk clinical.

The number of invasive disease-free survival events at the time of the analysis was 104 with Verzenio plus endocrine therapy compared with 158 with endocrine therapy alone. Overall survival data were not mature and additional follow up is ongoing.

“Over time, the collective results of the Verzenio clinical development program have demonstrated a differentiated CDK4/6 inhibitor profile, and the landmark data from the monarchE trial that supported this new indication in HR+ HER2- early breast cancer represent another important step forward for people who are in need of new treatment options,” Jacob Van Naarden, senior vice president and CEO of Loxo Oncology at Lilly and president of Lilly Oncology, said in a statement.

Sara M. Tolaney, M.D.

“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. We are encouraged by the marked reduction in the risk of recurrence even beyond the two-year treatment period in these patients, and I'm grateful to be able to offer this as a treatment option to my patients,” added Sara M. Tolaney, M.D., Harvard Medical School, Dana-Farber Cancer Institute, and investigator on the monarchE study.

Verzenio is available in 200 mg, 150 mg, 100 mg, and 50 mg tablets.

The labeling for Verzenio contains warnings and precautions for diarrhea, neutropenia, interstitial lung disease (ILD/pneumonitis), hepatotoxicity, venous thromboembolism, and embryo-fetal toxicity.