Daiichi Sankyo and AstraZeneca’s ENHERTU (trastuzumab deruxtecan) has secured approval in the European Union (EU) as a monotherapy to treat adult patients with advanced HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received an earlier trastuzumab-based regimen.
ENHERTU is a particularly engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialised by the two firms.
Around 136,000 cases of gastric cancer are diagnosed every year in Europe, where it stands as the sixth leading cause of cancer death.
Gastric cancer is usually diagnosed in the advanced stage, and even when the disease is diagnosed at initial stages, the survival rate remains modest.
Around one in five gastric cancers are HER2 positive.
The approval by the European Commission comes after the positive opinion of the Committee for Medicinal Products for Human Use in November 2022.
It also based on results from the DESTINY-Gastric02 and DESTINY-Gastric01 phase 2 trials.
Daiichi Sankyo president and CEO for Global Head of Oncology Business Ken Keller said: “ENHERTU is the first antibody drug conjugate to be approved in Europe for advanced gastric cancer, representing a major advance in treating this difficult-to-treat cancer.
“With this approval, we can now offer patients with previously treated HER2 positive gastric cancer a treatment with clinically meaningful efficacy.”
AstraZeneca Oncology Business Unit executive vice president Dave Fredrickson said: “Today’s important approval makes ENHERTU the first HER2 directed medicine to be approved for gastric cancer in the European Union in more than a decade.
“Patients across the EU with advanced HER2 positive disease who have progressed following treatment in the first-line setting may now have the potential opportunity to benefit from treatment with ENHERTU.”