FDA Approves Verzenio for Adjuvant Treatment of High-Risk Early Breast Cancer Subset

Verzenio marks the first CDK4/6 inhibitor approved by the FDA for the treatment of patients with hormone receptor-positive, HER2-negative early breast cancer.

The Food and Drug Administration (FDA) approved Verzenio (abemaciclib) in combination with endocrine therapy for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer.

Verzenio is the first and only CDK4/6 inhibitor (drugs designed to interrupt cancer cell growth by targeting enzymes called CDK4 and CDK6) approved by the FDA for this specific patient population, according to a release from the drug’s manufacturer, Eli Lilly and Company.

“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-positive, HER2-negative) early breast cancer represent another important step forward for people who are in need of new treatment options,” said Jacob Van Naarden, senior vice president and CEO of Loxo Oncology at Lilly and president of Lilly Oncology, in the release. “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.”

This FDA approval was based on findings from the phase 3 monarchE trial, during which men and women with HR-positive, HER2-negative early breast cancer were assigned 150 mg of Verzenio twice per day for two years plus standard endocrine therapy or standard endocrine therapy alone. Both groups were instructed to receive adjuvant endocrine therapy for up to five to 10 years based on their clinician’s recommendation. The main objective of this trial was to assess invasive disease-free survival (the length of time before breast cancer recurs, any new cancer develops or death). Patients assigned Verzenio plus hormone therapy had a significant improvement in invasive disease-free survival compared with those who received endocrine therapy alone.

“The design and results of the monarchE study are practice-changing and represent the first advancement in adjuvant treatment of (HR-positive, HER2-negative) breast cancer in a very long time,” said study investigator Dr. Sara M. Tolaney, of Harvard Medical School, Dana-Farber Cancer Institute in Boston, in the release. “This FDA approval of 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.”

The approval by the FDA was also based on an analysis of the monarchE trial of patients with HR-positive, HER2-negative early breast cancer and high-risk disease. In this analysis with additional follow-up, patients treated with Verzenio plus endocrine therapy had a 37% decrease in the risk for breast cancer occurrence or death versus endocrine therapy alone. There was also an absolute benefit in invasive disease-free survival of 7.1% at three years. In particular, patients assigned the combined treatment had 104 events compared with 158 among those treated with endocrine therapy alone.

Several side effects were observed with Verzenio during the monarchE trial, with the most common being diarrhea, fatigue, infections, headache, nausea, stomatitis, vomiting, dizziness, decreased appetite, hair loss and rash, according to the release. Several common laboratory abnormalities occurred in patients assigned combination therapy including a decrease in white blood cell count, increase in creatinine, decrease in neutrophil count, decrease in lymphocyte count, anemia and decreased platelet count, among others.

“Women and men living with high-risk (HR-positive, HER2-negative) early breast cancer want to do all they can do reduce the risk of the disease coming back, with the hope of living free of cancer,” said Jean Sachs, CEO of Living Beyond Breast Cancer, in the release. “The approval of Verzenio provides a new treatment option to help them do just that. This approval brings new optimism to the breast cancer community.”

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