National Institute for Health and Clinical Excellence (NICE)
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NICE recommends step-change targeted treatment for people with early breast cancer

Around 4,000 people are set to benefit from a step-change in treatment for early breast cancer following today’s (17 June 2022) provisional approval by NICE of abemaciclib in combination with hormone therapy as an option after surgery

NICE’s final draft guidance recommends abemaciclib (also called Verzenios and made by Eli Lilly) for people with hormone receptor-positive, HER2-negative, node-positive early breast cancer at high risk of recurrence who have had surgery to remove their tumour.

Results from a clinical trial showed that people having abemaciclib with hormone therapy had a more than 30% better chance of their cancer not coming back following surgery compared with people having hormone therapy alone.

Taken as a twice-daily pill, abemaciclib works by targeting and inhibiting proteins in cancer cells which allow the cancer to divide and grow.

Health and Social Care Secretary Sajid Javid said: “We are constantly looking for new and innovative cancer treatments, and the UK has proven itself to be a pioneer in finding and deploying the most ground-breaking medicines the world has to offer.

“This new drug will mean thousands of breast cancer patients will have a higher chance of recovering from this disease and spending more precious time with their loved ones.

“This is another fantastic step forwards in our ambition to make the UK one of the best countries in Europe for cancer care, which will be a key focus in my 10-Year Cancer Plan being published this summer.”

Helen Knight, interim director of medicines evaluation at NICE, said: “Today’s positive draft recommendation, which comes less than a month after abemaciclib received its licence, is fantastic news. The fact that we have been able to produce draft recommendations so quickly is testament to the success of our ambition to support patient access to clinically and cost effective treatments as early as possible.

“Until now there have been no targeted treatments for people with this type of breast cancer. Abemaciclib with hormone therapy represents a significant improvement in how it is treated because being able to have a targeted treatment earlier after surgery will increase the chance of curing the disease and reduce the likelihood of developing incurable advanced disease.”

Professor Peter Johnson, National Clinical Director for Cancer for NHS England, said: “Thanks in part to this latest deal struck by NHS England, NHS patients will be able to access another new targeted drug for a common and aggressive form of breast cancer. 

“Abemaciclib, when used alongside a hormone therapy, offers a new doubly targeted treatment option, helping to increase the chances of beating the cancer for good, as well as meeting the NHS’ commitment to delivering improved cancer care under our Long Term Plan.”

Treatment with chemotherapy or hormone therapy, or both, has remained the standard of care for many years for people with hormone receptor-positive, HER2-negative, node-positive early breast cancer at high risk of recurrence following surgery.

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.

NICE has made positive recommendations in all 11 of its completed appraisals of breast cancer medicines since March 2018, with a 12th (pembrolizumab combination for advanced triple negative breast cancer) due for publication later this month. On completion of this appraisal that number will be 13. These are all now available for clinicians to use in the treatment of NHS patients.

Read the draft guidance on abemaciclib with hormone therapy for early breast cancer following surgery here:

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