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Breast CancerFDA Approvals, News & UpdatesNewsworthy

Verzenio Approved as Initial Treatment for Metastatic Breast Cancer

The CDK4/CDK6 inhibitor Verzenio received a new indication, for use alone or in combination with an aromatase inhibitor, as initial therapy in women with HR-positive, HER2-negative advanced or metastatic breast cancer.
May 2018 Cancer Biomarkers and Molecular Testing

On February 26, 2018, the FDA approved a new indication for Verzenio (abemaciclib; from Eli Lilly), a CDK4/CDK6 inhibitor, for use alone or in combination with an aromatase inhibitor, as initial endocrine-based therapy in postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer.

“This approval is an important milestone, as it shows that Verzenio plus an aromatase inhibitor substantially reduced tumor size and delayed disease progression in women with hormone receptor-positive, HER-2-negative metastatic breast cancer,” said Joyce O’Shaughnessy, MD, Chair of the Breast Cancer Research Program at Baylor University Medical Center, TX, in a press release. “This information will help inform treatment decisions for each patient, which can be complicated in advanced breast cancer.”

Verzenio was first approved last year for use alone in patients with HR-positive, HER2-negative advanced or metastatic breast cancer progressing after endocrine therapy and chemotherapy, or in combination with Faslodex (fulvestrant) for advanced or metastatic breast cancer progressing after endocrine therapy. In clinical trials, patients who received Verzenio had twice as long a period (28.2 months) without the cancer progressing compared with 14.8 months with placebo.

The most common side effect with Verzenio is diarrhea. Other common side effects are neutropenia, fatigue, infections, nausea, abdominal pain, anemia, vomiting, alopecia, decreased appetite, and leukopenia.

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Last modified: July 17, 2018

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