Astrazeneca's Enhertu granted EC Decision in HER2-low metastatic breast cancer

AstraZeneca has announced that the European Commission has granted its Decision for Enhertu (trastuzumab deruxtecan) extension of indication as monotherapy for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy.

As a reminder, Enhertu extension of indication was granted a positive CHMP Opinion in December 2022, based on results from the DESTINY-Breast04 Phase III trial.

Reference link: Astrazeneca press release