Jointly developed by AstraZeneca and Daiichi Sankyo, Enhertu is claimed as the first HER2-directed therapy that showed a significant survival benefit compared to chemotherapy in the targeted patient population
Enhertu is jointly developed and commercialised by AstraZeneca and Daiichi Sankyo. (Credit: AstraZeneca)
AstraZeneca has announced that the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has recommended Enhertu (trastuzumab deruxtecan) as monotherapy for HER2-low breast cancer.
The recommendation is for adult patients whose cancer is unresectable or metastatic and who went through prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of adjuvant chemotherapy.
Enhertu is a HER2-directed antibody drug conjugate (ADC), which has been jointly developed and commercialised by AstraZeneca and Japan-based pharmaceutical firm Daiichi Sankyo.
The CHMP’s positive opinion was based on results from the DESTINY-Breast04 phase 3 trial. The late-stage study evaluated the efficacy and safety of the ADC by randomising 557 participants in a ratio of 2:1 to receive either Enhertu or chemotherapy.
As per the findings, the breast cancer drug lowered the risk of disease progression or death by 50% compared to physicians’ choice of chemotherapy in patients with HER2-low metastatic breast cancer with HR-positive or HR-negative disease.
AstraZeneca oncology R&D EVP Susan Galbraith said: “Enhertu is the first-ever HER2-directed medicine to show a survival benefit in patients with HER2-low metastatic breast cancer, confirming the importance of targeting lower levels of HER2 expression in patients previously classified as HER2-negative.
“The CHMP’s recommendation is encouraging and supports our ambition to evolve the way breast cancer is classified and treated to ultimately improve patient outcomes.”
Additionally, the ADC has been approved in the EU as monotherapy for the treatment of advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.
The approval is indicated for adult patients who have been subjected to a prior trastuzumab-based regimen.
In another development, AstraZeneca’s Forxiga (dapagliflozin) has been recommended by CHMP for approval in the EU to extend its indication for heart failure with reduced ejection fraction (HFrEF) to cover patients across left ventricular ejection fraction (LVEF).
The positive opinion was based on results from the DELIVER phase 3 trial in which Forxiga reduced the composite outcome of cardiovascular death or worsening of heart failure by 18%.
The UK-based drug firm also announced that Imfinzi and Imjudo combinations have been suggested for receiving marketing authorisation in the EU for advanced liver and lung cancers.