Enhertu granted FDA Breakthrough status

UK pharma major AstraZeneca (LSE: AZN) and Japan’s Daiichi Sankyo’s (TYO: 4568) Enhertu (trastuzumab deruxtecan) has been granted Breakthrough Therapy designation (BTD) in the USA for adult patients with HER2-positive early breast cancer with residual invasive disease in the breast and/or axillary lymph nodes after neoadjuvant treatment and high risk of disease recurrence.

The Food and Drug Administration (FDA) BTD accelerates the development and regulatory review of potential new medicines intended to treat a serious condition and address a significant unmet medical need. The FDA granted this BTD based on results from the DESTINY-Breast05 Phase III trial presented in a Presidential Symposium at the 2025 European Society for Medical Oncology (ESMO) Congress.

Last week, the FDA approved Enhertu in combination with pertuzumab for the 1st-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer. Also earlier this month Daiichi won a patent dispute on the drug with Seagen.