Eli Lilly’s Verzenio Picks Up Third Approved Indication

Eli Lilly

Eli Lilly snagged regulatory approval for expanded use of cancer treatment Verzenio. The latest approval marks the third time over the past five months the U.S. Food and Drug Administration has given the drug the green light.

On Monday the FDA gave the go-ahead for the Verzenio to be used in combination with an aromatase inhibitor (AI) to treat some breast cancer patients. The combination therapy was approved for treatment of postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer. Verzenio, a cyclin-dependent kinase (CDK)4 and CDK6 inhibitor, was first approved in September. The FDA approval made Verzenio the first drug of its class to be approved in in combination with fulvestrant and as a single agent in metastatic breast cancer.

Verzenio’s latest approval was based on data from the pivotal late-stage MONARCH 3 clinical trial, which was presented last year in Madrid at the European Society for Medical Oncology meeting. Trial data showed that Verzenio (abemaciclib) was able to cut disease progression or death by 46 percent. By adding abemaciclib to endocrine therapy as part of a treatment regimen, Eli Lilly said the program demonstrated improved progression-free survival in patients with HR+/HER2-negative breast cancer. In patients with measurable disease, the objective response rate was 59 percent in the abemaciclib arm and 44 percent in the placebo arm, according to data.

During the Madrid conference Levi Garraway, senior vice president of global development and medical affairs at Eli Lilly, told BioSpace that the drug has been developed as a medicine “that could be dosed continuously, in hopes of maximizing its treatment effect, to shrinking tumors and improving outcomes for patients.” That continuous dosing is something Lilly believes could give the drug an advantage of rival inhibitors in the same space, including Pfizer’s Ibrance and Novartis’ Kisqali.

Joyce O'Shaughnessy, chair of Baylor University’s Breast Cancer Research Program, called the expanded approval an important milestone because it shows “that Verzenio plus an aromatase inhibitor substantially reduced tumor size and delayed disease progression in women with HR+, HER2- metastatic breast cancer.” O'Shaughnessy added that the MONARCH 3 trial included patients with concerning clinical characteristics, such as a pattern of disease that spread to the liver that helps providers determine care options for patients with complicated breast cancer cases.

"The speed with which our team has been able to work with the FDA to gain approval for this additional Verzenio indication underscores Lilly's commitment to delivering meaningful medicines that can help more people living with advanced breast cancer. Verzenio has now been developed, studied and clinically proven in three key trials to be effective for women with HR+, HER2- metastatic breast cancer – helping to ensure we are providing support to those who need it most,” Sue Mahony, president of Lilly Oncology said.

The most common adverse reactions in the MONARCH 1, 2, and 3 trials were diarrhea, neutropenia, nausea, abdominal pain, infections, fatigue, anemia, leukopenia, decreased appetite, vomiting, headache, alopecia, and thrombocytopenia.

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