Abemaciclib (Verzenios) has been approved by the National Institute for Health and Care Excellence (NICE) to treat some people with breast cancer that has a high-risk of returning. The new drug combination will be available to adults with hormone receptor-positive, HER-2 negative, node positive breast cancer, on the NHS in England.
The targeted drug has been recommended alongside hormone therapy as a treatment option to reduce the risk of cancer returning after surgery.
Abemaciclib was approved as a routine treatment for advanced breast cancer in August 2021. However, the drug will now also be available to people in the early stages of the disease who have:
- At least 4 positive axillary lymph nodes (A lymph node in the area of the armpit (axilla) where cancer has spread to)
- 1 to 3 positive axillary lymph nodes, and either grade 3 disease (which tends to be fast growing) or a primary tumour size of at least 5cm
Abemaciclib plus hormone therapy offers a targeted treatment option earlier in the treatment pathway. Clinicians told NICE this option can improve quality of life, increase the chance of curing the disease, and reduce the risk of developing incurable advanced disease.
– Rose Gray, head of policy development at Cancer Research UK
How does it work?
Abemaciclib is a type of cancer growth blocker that targets the proteins cyclin dependant kinase 4 and 6 (CDK4 and CDK6) on breast cancer cells.
CDK4 and CDK6 are proteins that stimulate cancer cells to divide and grow. By blocking these proteins, abemaciclib aims to slow or stop cancer growth.
Human versions of cyclin-dependent kinases were discovered by Paul Nurse, a Cancer Research UK scientist at the London Research Institute. For this discovery, Nurse was jointly awarded the Nobel Prize in 2001, along with his colleague Tim Hunt and US researcher, Leland Hartwell, who first identified cyclin dependent kinases in yeast.
Improving life after recovery
Breast cancer is the most common cancer in the UK. Hormone receptor-positive, HER2-negative breast cancer is the most common subtype, accounting for about 70% of all breast cancers.
Treatment options are limited for this type of cancer and many come with unpleasant side effects that make completing treatment difficult for lots of people.
This new treatment pathway brings new hope for people with HER2-negative breast cancer and their families, offering fewer side effects and less fear of cancer returning after treatment.
“This decision is good news for people affected by this type of early breast cancer. The risk of the cancer returning after initial treatment can cause real stress and anxiety for patients and their families,” says Gray.
Reducing the risk of cancer returning
The decision comes after success from the monarchE trial, which found treatment with abemaciclib to be hugely effective in lowering the risk of recurring breast cancer after surgery.
The ongoing trial involved 5,637 people with hormone receptor-positive, HER2-negative, node-positive early breast cancer.
Chemotherapy followed by hormone therapy is standard care for adjuvant treatment for this type of cancer. The study found that people treated with abemaciclib plus hormone therapy lived longer without any signs of invasive cancer, compared to hormone therapy alone.
The study results showed that after 2 years, the percentage of people with no signs of invasive cancer was 92.2% versus 88.7% for people on hormone therapy alone.
The longer-term benefits of abemaciclib with hormone therapy remain uncertain at this stage, as data is still being collected.
The cost-effectiveness estimates are also uncertain, but the most likely estimates are within the range NICE considers an acceptable use of NHS resources. Therefore, abemaciclib is recommended.
NICE decisions are usually adopted in Wales and Northern Ireland as well, so the decision is likely to affect patients in all 3 nations. Scotland has a separate process for reviewing drugs.