Regulatory Affairs

Lilly’s breast cancer drug Verzenio secures another approval in US

PBR Staff Writer Published 27 February 2018

Eli Lilly and Company has secured additional approval from the US Food and Drug Administration (FDA) for Verzenio (abemaciclib) as initial treatment for advanced breast cancer.

It marks the third approval from the US regulator for the breast cancer treatment in five months.

The latest approval allows Eli Lilly to use Verzenio in combination with an aromatase inhibitor (AI) as initial endocrine-based therapy for treating postmenopausal women with advanced or metastatic breast cancer, who are hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-).

According to Lilly, Verzenio has been designed to specifically inhibit the cyclin-dependent kinase (CDK) 4 and 6 cyclin-dependent kinases, whose increased signaling results in uncontrolled cell growth in various cancers.

Verzenio in combination with an AI is recommended to be taken in a 150mg dose, orally twice a day, until disease progression or toxicity levels become unacceptable, said Lilly.

The Verzenio combo’s approval was driven by the efficacy and safety data recorded from the phase 3 MONARCH 3 clinical trial, which featured 493 postmenopausal women with HR+, HER2- advanced breast cancer, who previously did not undergo systemic treatment for advanced disease.

Verzenio, in combination with AIs like anastrozole or letrozole, was shown to have significantly pushed back disease progression, in comparison to the combination of placebo with one of the AIs.

Lilly Oncology senior vice president and president Sue Mahony said: "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."

In September 2017, Verzenio was approved in combination and also as a single agent in metastatic breast cancer.

It was approved in combination with fulvestrant for treating women with HR+, HER2- advanced or metastatic breast cancer, whose disease had progress after endocrine therapy.

On the other hand, Verzenio’s approval as a monotherapy is for treating adult patients with HR+, HER2- advanced or metastatic breast cancer whose disease had progressed after endocrine therapy and prior chemotherapy in the metastatic setting.

Image: Eli Lilly and Company's global headquarters, in Indianapolis, Indiana. Photo: courtesy of Guanaco152003/