By VETTAPHARMA reporter – Derek Roche: AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) received U.S. FDA approval for two new indications in HER2-positive early breast cancer, expanding its use into both neoadjuvant and adjuvant treatment settings.
In the neoadjuvant setting, Enhertu followed by taxane, trastuzumab, and pertuzumab (THP) was approved for adults with HER2-positive Stage II or III breast cancer, based on results from the DESTINY-Breast11 Phase III trial.
In the adjuvant setting, Enhertu was approved for adults with HER2-positive breast cancer with residual invasive disease following trastuzumab-based neoadjuvant therapy, supported by findings from the DESTINY-Breast05 Phase III trial.
The DESTINY-Breast05 study demonstrated that Enhertu reduced the risk of invasive disease recurrence or death by 53% compared with trastuzumab emtansine (T-DM1), with a three-year invasive disease-free survival rate of 92.4% versus 83.7%.
The approvals further expand Enhertu’s clinical footprint across HER2-positive breast cancer, with the therapy now approved in the U.S. across both early-stage and metastatic disease settings.
The programme reflects AstraZeneca and Daiichi Sankyo’s strategy of advancing HER2-directed antibody-drug conjugates (ADCs) across multiple stages of breast cancer, with continued focus on earlier intervention and long-term disease control.
For patients, the approvals introduce additional treatment options aimed at reducing recurrence risk and improving long-term outcomes in HER2-positive early breast cancer, particularly for individuals with residual disease following initial therapy.
From a commercial perspective, the expansion into early breast cancer settings strengthens Enhertu’s position within the HER2 treatment landscape and may support continued growth as use expands into broader patient populations and earlier lines of therapy.
