The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and is based on results from a subgroup of patients with HER2-positive (IHC 3+) tumors across three Phase II trials, DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02.

“Precision medicine is reshaping cancer care by helping inform treatment decisions based on the molecular and biological characteristics of a patient’s disease. Enhertu is already approved in breast, gastric, and lung cancers, and with this approval, clinicians may now consider Enhertu for patients with HER2-positive status across multiple additional tumour types. This highlights the importance of biomarker testing to identify eligible patients and ensure that those with HER2-positive disease are considered for targeted treatment,” says Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca.

​Enhertu

Additional regulatory submissions for Enhertu are under review in the EU, including in combination with pertuzumab for the 1st-line treatment of patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer based on data from the DESTINY-Breast09 Phase III trial and for patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease after neoadjuvant HER2-targeted treatment based on data from the DESTINY-Breast05 Phase III trial.

​Enhertu is a specifically engineered HER2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo. 

Financial considerations

Following this approval in the EU, an amount of USD 25 million is due from AstraZeneca to Daiichi Sankyo as a milestone payment for the tumour-agnostic indication. Sales of Enhertu in most EU territories are recognised by Daiichi Sankyo.

HER2 expression in solid tumours

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of various tissue cells throughout the body and is involved in normal cell growth. HER2 protein overexpression may occur as a result of HER2 gene amplification and is often associated with aggressive disease and poor prognosis in some cancers. HER2 overexpression occurs in a range of solid tumors with the prevalence varying by tumor type.

HER2-directed therapies have been used to treat HER2 overexpression in breast, gastric and biliary tract cancers in the EU. Although HER2 is overexpressed in additional solid tumor types including lung, bladder, cervical, colorectal, endometrial, ovarian, salivary gland and pancreatic cancers, HER2 testing is not routinely performed for these additional tumor types and prior to this approval there were no HER2-directed treatments approved in the EU to treat a broad range of solid tumors.