MHRA extends indication for AstraZeneca and Daiichi Sankyo's Enhertu

Japanese drugmaker Daiichi Sankyo (TYO: 4568) and UK pharma major AstraZeneca (LSE: AZN) have announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has extended the conditional marketing authorization for Enhertu (trastuzumab deruxtecan) as a monotherapy for the treatment of adult patients in Great Britain with unresectable or HER2-positive metastatic breast cancer who have received one or more prior anti-HER2-based regimens.

The marketing authorization is based on positive results from the DESTINY-Breast03 Phase III trial, which showed trastuzumab deruxtecan reduced the relative risk of disease progression or death by 72% versus trastuzumab emtansine in patients with HER2-positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane.

The safety of trastuzumab deruxtecan was evaluated in 257 patients with unresectable or metastatic HER2 positive breast cancer who received at least one dose of Enhertu (5.4mg/kg).