AstraZeneca and Daiichi Sankyo have received FDA approval for ENHERTU (fam-trastuzumab deruxtecan-nxki) in two new indications for HER2-positive early breast cancer – both before surgery (neoadjuvant) and after surgery (adjuvant) – marking the drug’s expansion from metastatic disease into the curative-intent setting.
The approvals are significant because while HER2-positive early breast cancer is considered highly curable, up to one in four patients still experience disease recurrence. Once breast cancer becomes metastatic, the five-year survival rate drops from nearly 90% to approximately 30%.
In the neoadjuvant setting (DESTINY-Breast11 trial), ENHERTU followed by standard therapy achieved a pathologic complete response rate of 67.3% compared to 56.3% for the current standard regimen – meaning more patients had no evidence of invasive cancer cells remaining after treatment.
In the adjuvant setting (DESTINY-Breast05 trial), ENHERTU reduced the risk of invasive disease recurrence or death by 53% compared to trastuzumab emtansine (T-DM1). At three years, 92.4% of patients in the ENHERTU arm were alive and free of invasive disease, compared with 83.7% on T-DM1. Results were published in The New England Journal of Medicine.
“HER2-positive breast cancer is an aggressive disease, and our goal is to reduce the risk of recurrence for patients as early as possible to achieve the best long-term outcomes,” said Shanu Modi, MD, medical oncologist at Memorial Sloan Kettering Cancer Center. “These two new indications in HER2-positive early breast cancer will evolve how we treat patients in these settings and support trastuzumab deruxtecan as a potential new standard of care in early-stage disease.”
ENHERTU is already approved in more than 95 countries for metastatic breast cancer and now holds six breast cancer indications in the U.S. spanning early-stage, metastatic, HER2-positive, HER2-low, and HER2-ultralow disease. It is one of several major breast cancer therapy advances in this publishing cycle, alongside Arvinas/Pfizer’s VEPPANU approval (the first PROTAC therapy), Artera’s AI-powered risk stratification clearance, and ScreenPoint Medical’s AI detection funding.
