FDA approves Enhertu for early HER2-positive breast cancer, both before and after surgery

Daiichi Sankyo/Enhertu

Enhertu moved into curative-intent treatment with two US approvals for early HER2-positive breast cancer. Before surgery (DESTINY-Breast11), Enhertu followed by standard HER2 therapy cleared the tumour in more patients than anthracycline chemotherapy. After surgery in patients with leftover cancer (DESTINY-Breast05), it beat T-DM1, the previous standard, on keeping the disease from returning.

• DB-11 (927 patients): pathologic complete response 67.3% vs 56.3%.
• DB-05 (1,635 patients): 3-year invasive disease-free survival 92.4% vs 83.7%.
• Adjuvant course: 5.4 mg/kg every 3 weeks for up to 14 cycles.