Eli Lilly’s Verzenio cleared by FDA as first line therapy in advance metastatic breast cancer

U.S. Food and Drug Administration (FDA) today cleared Eli Lilly’s VerzenioTM (abemaciclib) for use as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer in combination with an aromatase inhibitor (AI).

Verzenio has already received FDA’s approval as first and only cyclin-dependent kinase (CDK)4 & 6 inhibitor approved as a single agent or in combination in metastatic breast cancer.

It is used alone to treat adults with HR-positive, HER2–negative advanced breast cancer or metastatic breast cancer whose disease has progressed after hormonal therapy and prior chemotherapy.

It is specifically used in combination with fulvestrant to treat women with hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)–negative advanced breast cancer or breast cancer that has metastasized to after hormonal therapy.

The initial approval of Verzenio followed the results of MONARCH 3 trial (ClinicalTrials.gov: NCT02246621) which suggested that initial abemaciclib improves progression-free survival (PFS) among patients with hormone receptor-positive, HER2-negative advanced breast cancer. The findings were published in the Journal of Clinical Oncology.

In the trial it was seen that patient receiving abemaciclib plus an AI (anastrozole or letrozole) has nearly double progression-free survival(PFS) as compared to patients receiving placebo plus AI (28.2 months vs 14.8 months).

The combination of abemaciclib plus AI also provides 46% more chances of survival as compared to abemaciclib plus placebo (HR: 0.54; 95% CI: 0.418-0.698, P <0.0001).

It also resulted in significant tumor shrinkage in 59 percent of patients compared with 44 percent of those who received endocrine drugs alone in the study.

Richard Pazdur, the FDA’s head of oncology drug evaluation, said in a statement, “Verzenio provides a new targeted treatment option for certain patients with breast cancer who are not responding to treatment, and unlike other drugs in the class, it can be given as a stand-alone treatment to patients who were previously treated with endocrine therapy and chemotherapy.”

Verzenio is given as oral 150mg two-times-a-day dose; thus, eliminating the need for patients to get admitted for infusion. Lilly’s Verzenio competes with Pfizer's Ibrance and Kisqali from Novartis. 

The most common side effects are diarrhea, neutropenia, and Liver problems. It is contraindicated in pregnancy.

Breast cancer is the most common cancer in women worldwide and it is estimated that 266,120 new cases of invasive breast cancer will be diagnosed in women in the U.S. in 2018.

This Verzenio new drug application received clearance as a part of the FDA's Expedited Programs for Serious Conditions, specially reserved for therapies that address an unmet medical need in the treatment of serious or life-threatening conditions, such as metastatic breast cancer.

According to Lilly, Verzenio will be in the market in October in the US.

Abstract

Lilly's News Release