Lilly Updates Safety Labeling for the Anticancer Therapy Verzenio

The studies conducted to support Verzenio’s most recent approval for the treatment of high-risk early breast cancer provided additional safety data.

Eli Lilly has updated the warnings and safety precautions section of the labeling for Verzenio (abemaciclib). Specifically, the sections regarding the risks for neutropenia and interstitial lung disease or pneumonitis now include data from the monarchE trial, which was conducted to support the therapy’s most recent approval.

In October, the FDA approved Verzenio to treat patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), high risk, early breast cancer. Verzenio is a CDK4/6 inhibitor that is also approved for certain types of HR+, HER2-advanced, or metastatic breast cancer.

Related: FDA Clears Lilly’s Verzenio for Early Breast Cancer

Published in the Annals of Oncology on Oct. 14, 2021 and presented at the same time at a ESMO Virtual Plenary session, the study found a higher incidence of grade three or higher adverse events when Verzenio is added to estrogen therapy compared with estrogen therapy alone. In total, 6.5% of patients discontinued treatment in the Verzenio arm compared with 1.1% in the control arm.

The neutropenia section of the label now reads (with changes underlined):

“Neutropenia, including febrile neutropenia and fatal neutropenic sepsis, occurred in patients treated with Verzenio.

Across four clinical trials in 3,691 patients, neutropenia occurred in a 37% to 46% of patients receiving Verzenio. A grade greater than or equal to three decrease in neutrophil count (based on laboratory findings) occurred in 19% to 32% of patients receiving Verzenio. Across trials, the median time to the first episode of grade greater than or equal to three neutropenia ranged from 29 days to 33 days, and the median duration of grade greater than or equal to three neutropenia ranged from 11 days to 16 days.

Febrile neutropenia has been reported in <1% of patients exposed to Verzenio across trials. Two deaths due to neutropenic sepsis were observed in MONARCH 2. Inform patients to promptly report any episodes of fever to their health care provider.”

The interstitial lung disease or pneumonitis section now reads (with changes underlined):

“Severe, life-threatening, or fatal interstitial lung disease (ILD) or pneumonitis can occur in patients treated with Verzenio and other CDK4/6 inhibitors. In Verzenio-treated patients in early breast cancer (monarchE, N=2791), 3% of patients experienced ILD or pneumonitis of any grade: 0.4% were Grade 3 or 4 and there was one fatality (0.1%). In Verzenio-treated patients in advanced or metastatic breast cancer (N=900) (MONARCH 1, MONARCH 2, MONARCH 3), 3.3% of Verzenio-treated patients had ILD or pneumonitis of any grade: 0.6% had Grade 3 or 4, and 0.4% had fatal outcomes. Additional cases of ILD or pneumonitis have been observed in the postmarketing setting, with fatalities reported.”