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Eli Lilly’s Verzenios recommended by NICE as combination therapy for early-stage breast cancer

The trial results showed a drop of 32% in cancer recurrence when using Verzenios in combination with endocrine therapy

Eli Lilly

Eli Lilly’s Verzenios (abemaciclib) has been recommended by the National Institute for Health and Care Excellence (NICE) as a treatment for early-stage breast cancer in combination with endocrine therapy.

The recommendation is specifically for adult patients with hormone receptor-positive, HER2-negative, node-positive early-stage breast cancer whose disease is at high risk of recurrence. It was based on results from the phase 3 randomised global monarchE trial, which met its primary endpoint.

The trial showed that adjuvant treatment using Verzenios in combination with endocrine therapy decreased the risk of breast cancer recurrence by 32%.

The NICE approval of Verzenios in combination with endocrine therapy makes it the first cyclin-dependent kinase (CDK) 4/6 inhibitor to be made available within NHS England for people with HR+, HER2-, node-positive early-stage breast cancer at high-risk of recurrence.

The availability of the combination treatment on the NHS is supported by interim funding from the Cancer Drugs Fund until routine NHS baseline funding is established.

The recommendation comes four weeks after a UK marketing authorisation was issued by the Medicines and Healthcare products Regulatory Agency (MHRA).

Professor Stephen Johnston, consultant medical oncologist and head of the breast unit at the Royal Marsden NHS Foundation Trust, Professor of breast cancer medicine at the Institute of Cancer Research, London and lead global principal investigator for the monarchE trial, said: “It’s a privilege to see the compelling results from the monarchE trial, which was a huge international effort, translate into a new treatment option for HR+ and HER2- breast cancer patients who have a high risk of their cancer recurring.

“Despite previously receiving the very best standard of care treatment, this high risk node-positive group represents about 5,000 breast cancer patients each year who are at a much higher risk of their disease returning.”

Johnston added that “abemaciclib is a significant breakthrough and is the first new treatment for this patient group in 20 years”.

Breast cancer is the most common cancer among women globally, and despite the prognosis for HR+, HER2- early-stage breast cancer being generally good, 20-30% of patients could progress to incurable metastatic disease.

Article by
Fleur Jeffries

17th June 2022

From: Research, Regulatory



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