Lilly's breast cancer drug Verzenio approved in EU
Eli Lilly’s Verzenio breast cancer drug has been approved in Europe, as the pharma prepares to compete with established rivals from Pfizer and Novartis.
Verzenio (abemaciclib) is a CDK4 and 6 inhibitor, and has been approved by the European Commission in women living with HR+, HER2- advanced breast cancer, in combination with an aromatase inhibitor or fulvestrant.
The drug can be used in women who have not received endocrine therapy, or women who have received this form of therapy.
Already approved in the US since last year, Verzenio will compete with Pfizer’s Ibrance (palbociclib), and Novartis’ Kisqali (ribociclib), which are in the same class of drugs, which work by interrupting the cycle of cell growth in tumours.
Ibrance is now Pfizer’s biggest selling cancer drug, with sales approaching $2 billion in the first six months of this year, although sales of Novartis’ Kisqali are far behind as the drug was second to the market.
Whether Eli Lilly’s drug will make any inroads remains to be seen, and there was no word from US pharma about pricing in Europe.
However in the US it has a list price before any discounts or rebates of about $10,948 per month.
Dr Arash Tahbaz, Senior Medical Director, Eli Lilly and Company UK and Northern Europe, said: “Despite advancements in medicine, metastatic or advanced breast cancer remains a difficult-to-treat, diverse disease with a range of characteristics that can present differently in each individual.
“This marketing authorisation recognises the potential clinical benefit abemaciclib offers and represents continued progress towards helping more people living with this devastating disease.”
The approval is based on the efficacy and safety demonstrated in the global MONARCH 2 and MONARCH 3 clinical trials. MONARCH 2 was a Phase 3, randomised, double blind, placebo-controlled trial evaluating abemaciclib in combination with fulvestrant that enrolled 669 patients with HR+, HER2- metastatic breast cancer who progressed while on endocrine therapy.
The most commonly occurring adverse reactions observed with abemaciclib are diarrhoea, infections, neutropenia, anaemia, fatigue, nausea, vomiting and decreased appetite.