Lilly's Verzenios gets NICE blessing for early-stage breast cancer

Thousands more people with breast cancer in England look set to be eligible for routine treatment with Eli Lilly's Verzenios, after new guidance from NICE backed use of the drug after surgery for early-stage tumours.

The new advice means that around 4,000 people with hormone receptor-positive, HER2-negative, node-positive early breast cancer who are considered at high risk of recurrence after surgery can receive Verzenios (abemaciclib) in combination with standard hormone therapy, said the agency.

The CDK 4/6 inhibitor – given as a twice-daily pill – is already recommended by NICE for NHS use as a first-line therapy for locally advanced or metastatic breast cancer, along with other drugs in the class including Pfizer's Ibrance (palbociclib) and Novartis' Kisqali (ribociclib).

Use in the adjuvant (post-surgery) setting in early breast cancer is however an "important step change" in the way the disease is treated in the UK, said NICE, as it is the first drug in the class to be cleared for this use.

Its advice is based on results from the phase 3 monarchE trial, which showed that adjuvant treatment using Verzenios in combination with endocrine therapy decreased the risk of breast cancer recurrence by 32%.

"It's fantastic that thousands of women with this type of primary breast cancer will now have an additional treatment option available on the NHS to help further reduce the risk of the disease coming back," said Delyth Morgan, chief executive of the Breast Cancer Now patient organisation.

Around 50,000 people a year are diagnosed in England with breast cancer. HER2-negative breast cancer is the most common type, accounting for about 70% of all breast cancers. It is estimated that early breast cancer comes back after initial treatment in around 30% of people.

Morgan welcomed that the decision had come after the first meeting of NICE's appraisal committee, just a month after Verzenios was approved for the new use by the UK Medicines and Healthcare products Regulatory Agency (MHRA).

"Unfortunately, far too often breast cancer drugs are receiving initial provisional rejections for use on the NHS and requiring multiple committee meetings," she said.

"There is still work to be done to ensure positive outcomes can be reached quickly and NICE, NHS England and the pharmaceutical industry all have a role to play to ensure there are no avoidable delays for patients accessing new effective treatments."

Verzenio has a list price of £2,950 for a packet of 56 150mg-tablets, but Lilly has agreed an undisclosed discounted price for NHS England. The Scottish Medicines Consortium (SMC) is scheduled to make its decision on the drug in the coming months.