The National Institute for Health and Care Excellence (NICE) has recommended AstraZeneca (AZ) and Daiichi Sankyo’s Enhertu for use within the cancer drugs fund (CDF) for the treatment of previously-treated HER2-positive metastatic breast cancer.

NICE’s recommendation is based on results from the Phase II DESTINY-Breast01 trial of Enhertu in 184 patients with HER2-positive metastatic breast cancer who have received two or more prior anti-HER2-based therapies.

Results demonstrated a confirmed objective response rate (ORR) of 61.4% with Enhertu treatment, including a 6.5% complete response rate and a 54.9% partial response rate.

After a median follow-up of 20.5 months, the median duration of response (DoR) was 20.8 months, with Enhertu showing a generally tolerable safety profile.

“We are very proud to have worked with NICE, NHS England and the breast cancer community to make trastuzumab deruxtecan available, through the Cancer Drugs Fund, to eligible patient in England with HER2 positive metastatic breast cancer whose disease has progressed following treatment with two anti-HER2 directed therapies,” said Haran Maheson, commercial director for oncology, Daiichi Sankyo UK.

AZ UK and Daiichi Sankyo said that they will continue to work closely with NICE as additional data is collected throughout the managed access period for Enhertu.

During this time, eligible patients with HER2-positive breast cancer will be able to access Enhertu before NICE makes a decision on routine funding for the therapy on the NHS.

“This authorisation is a significant step forward for the many thousands of people in England living with HER2 positive metastatic breast cancer,” said Jo Taylor, founder of METUP UK, an advocacy group for people living with metastatic breast cancer.

“Disease progression in metastatic breast cancer patients is an unmet need beyond second line treatment and new medicines are essential in the challenge to suppress this incurable disease,” she added.

Around 54,000 breast cancer cases in women are diagnosed annually in the UK, with approximately one in five cases being HER2 positive.