Enhertu Nabs A First With UK Standalone Approval

Advanced Breast Cancer Treatment Is First New Cancer Drug Approved In 2021

16 Feb 2021

The UK conditional approval of Daiichi Sankyo/AstraZeneca’s advanced breast cancer drug Enhertu was issued in accordance with “transitional provisions” that apply to drugs that received a positive opinion from the European Medicines Agency before the end of the Brexit transition period.

Realistic pink ribbon, breast cancer awareness symbol, vector illustration — There is significant unmet clinical need for patients with HER2 positive metastatic breast cancer • Source: Shutterstock

Daiichi Sankyo/AstraZeneca’s Enhertu (trastuzumab deruxtecan) has become the first new cancer medicine to be authorized by the UK’s Medicines and Healthcare products Regulatory Agency since it became an independent regulator in January following the end of the Brexit transition period.

Enhertu has been granted conditional authorization in the UK as a monotherapy for the treatment of adult patients with unresectable...