FDA expands indication of Lilly’s Verzenio in advanced breast cancer

pharmafile | February 27, 2018 | News story | Manufacturing and Production, Sales and Marketing Cancer, Eli Lilly, FDA, Verzenio, breast cancer, pharma 

Eli Lilly is celebrating the news that its cyclin-dependent kinase (CDK) 4 & 6 inhibitor Verzenio (ademaciclib) has received approval from the FDA to expand its indication to include the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer in postmenopausal women when used in combination with an aromatase inhibitor (AI).

The approval was secured with the support of Phase 3 data which examined the efficacy of the treatment in 493 postmenopausal HR+, HER2- advanced breast cancer patients who had not previously received systemic treatment.

Verzenio, when taken twice daily at 150mg in combination with an AI, demonstrated a median progression-free survival time of 28.2 months, compared to 14.8 months for placebo with an AI. In addition, the drug displayed an objective response rate of 55.4% with 52.1% achieving a partial response and 3.4% achieving a complete response. This is compared to 40.2% with placebo, with no patients achieving complete response. Verzenio in combination with an AI also demonstrated a median duration of response of 27.4 months, compared to 17.5 months for placebo plus an AI.

“This approval is an important milestone, as it shows that Verzenio plus an aromatase inhibitor substantially reduced tumour size and delayed disease progression in women with HR+, HER2- metastatic breast cancer. Notably, the MONARCH 3 trial included patients with certain concerning clinical characteristics, such as a pattern of disease that spread to the liver,” explained Dr Joyce O’Shaughnessy, Celebrating Women Chair in Breast Cancer Research and Chair, Breast Cancer Research Program, Baylor University Medical Center, Texas Oncology and US Oncology in Dallas. “This information will help inform treatment decisions for each patient, which can be complicated in advanced breast cancer.”

The latest decision marks the third approved indication of Verzenio in five months, having been most recently authorised in September for HR+, HER2- advanced or metastatic breast cancer with disease progression following endocrine therapy, both as a monotherapy and in combination with fulvestrant. The move meant that Verzenio became the first and only CDK 4 & 6 inhibitor approved in combination and as a single agent in metastatic breast cancer.

“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,” commented Dr Sue Mahony, Senior Vice President and President of Lilly Oncology. “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.”

Matt Fellows

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