BRIEF—European nod for Enhertu in gastric cancer

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) has picked up a new approval in Europe, as a monotherapy in gastric cancer.

The nod was widely expected, following a positive recommendation from the European Medicines Agency’s scientists in November 2022.

The label expansion will include treatment of HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma, as a second-line option.

First approved in the USA in 2019, Enhertu is also used for the treatment of certain people with breast cancer and non-small cell lung cancer (NSCLC).

The decision is based on results from the Phase II DESTINY-Gastric02 and DESTINY-Gastric01 trials.

AstraZeneca’s executive vice president for oncology, Dave Fredrickson, said the nod “makes Enhertu the first HER2-directed medicine to be approved for gastric cancer in the European Union in more than a decade.”