Authorisation of the treatment is based on results from the phase 3 trial
Eli Lilly’s Verzenios (abemaciclib) has received a marketing authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA), in combination with endocrine therapy for the adjuvant treatment of patients with HR+, HER2-, high risk node-positive early breast cancer (EBC).
Breast cancer is the most common cancer among women worldwide, with 20-30% of patients diagnosed with HR+ or HER2- early breast cancer that could progress to incurable metastatic disease.
Treatment with Verzenios in combination with edocrine therapy reduced risk of breast cancer recurrence by 32%.
“This approval establishes abemaciclib as the first CDK4/6 inhibitor to be authorised for the treatment of HR+, HER2-, high risk early breast cancer and is the first successful addition to adjuvant ET in nearly two decades,” said Dr Jeff Yang, associate vice president, medical, Northern Europe at Eli Lilly. “We understand the importance of having treatment options and are proud abemaciclib is now available for patients.”
The approval was based on results from the phase 3 monarchE trial, which met its primary endpoint. The trial involved a huge international effort of 5,637 patients with HR+, HER2-, high risk EBC from over 38 countries.
Professor Stephen Johnston, consultant medical oncologist and head of the breast unit at the Royal Marsden NHS Foundation Trust, reflected: “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 – about 15% of all HR+ and HER2- breast cancer patients – were at considerable risk of their disease returning. This drug represents a significant breakthrough and I’m delighted that it will be available for eligible patients to help reduce their risk of recurrence,” he added.