Enhertu accepted via cancer drugs fund for HER2-positive breast cancer
20th April 2021
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.
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UK conditionally approves new treatment for HER2 positive breast cancer
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The UK has conditionally approved Enhertu
® (trastuzumab deruxtecan) as a monotherapy for the treatment of unresectable or metastatic HER2 positive breast cancer based on Phase II trial results.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional marketing authorisation to Enhertu
® (trastuzumab deruxtecan) as a monotherapy for the treatment of adult patients with unresectable or metastatic human epidermal growth factor receptor 2 (HER2) positive breast cancer who have received two or more prior anti-HER2 based regimens.
The drug, developed by Daiichi Sankyo UK Ltd
and AstraZeneca, was authorised based on results from the Phase II DESTINY-Breast01 trial of trastuzumab deruxtecan (5.4 mg/kg) in 184 patients with HER2 positive metastatic breast cancer. As of the data cut-off in June 2021, the drug demonstrated a confirmed objective response rate of 61.4 perce