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August 13, 2021updated 17 Aug 2021 9:14am

NICE recommends Lilly’s abemaciclib for advanced breast cancer

Final guidance on the use of abemaciclib plus fulvestrant for HR+, HER2- metastatic breast cancer is anticipated next month.

The UK’s National Institute for Health and Care Excellence (NICE) has recommended Eli Lilly’s abemaciclib as an option for adults with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer that has spread to other body parts.

Marketed as Verzenios, abemaciclib is a CDK4/6 inhibitor, which works by hindering proteins in cancer cells that cause the division and growth of the tumour.

As per the NICE draft guidance, abemaciclib is indicated for use as a twice-daily pill along with the hormonal therapy drug, fulvestrant, in adults who have already received hormonal treatment.

The positive recommendation comes after an improved patient access scheme from Lilly.

Based on this scheme and additional economic modelling data submitted by the company, NICE recommended the drug as a cost-effective use of NHS resources.

The committee learned about using abemaciclib as an additional therapy option during consultation on the prior draft recommendations.

Compared to other existing drugs, abemaciclib is an alternative CDK4/6 inhibitor and has dissimilar side effects. This provides an option to manage the side effects linked to these drugs.

NICE Centre for Health and Technology Evaluation director Meindert Boysen said: “The committee heard that CDK4/6 inhibitors like abemaciclib were welcomed by patients because they can delay the time before their cancer gets worse and so delay or avoid the need for chemotherapy.

“The committee also heard from the patient experts that exemestane plus everolimus, the treatment that would normally be used at this stage, was poorly tolerated and used for only a small number of people because it has similar effects to chemotherapy on quality of life.

“We are therefore very pleased to be able to recommend that abemaciclib with fulvestrant can now be provided routinely as another option for people with advanced breast cancer who have already had endocrine therapy.”

With the latest recommendation, abemaciclib will now be excluded from the Cancer Drugs Fund, NICE noted.

Furthermore, the drug will be available routinely as an option where exemestane, along with everolimus, would be the best alternative therapy to a CDK 4/6 inhibitor.

The organisation anticipates issuing the final guidance on abemaciclib along with fulvestrant for HR+, HER2- metastatic breast cancer next month.

In February 2018, the US Food and Drug Administration approved Verzenio for patients with HR+, HER2- advanced or metastatic breast cancer.

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