MAY 15 2026
Daiichi Sankyo — Enhertu (fam-trastuzumab deruxtecan-nxki) $DSKYF
for HER2-positive breast cancer
FDA approved Enhertu for two new indications in HER2-positive breast cancer patients in neoadjuvant and adjuvant settings.
About
HER2-positive breast cancer is an aggressive form of the disease where tumors overproduce the HER2 protein, often leading to rapid growth and spread. Enhertu is an antibody-drug conjugate that delivers chemotherapy directly to HER2-positive cells while sparing healthy tissue. By targeting HER2 with precision, it may help slow tumor progression and reduce side effects compared to traditional chemotherapy.
Pivotal trial
This phase III trial evaluates the effect of adding locoregional therapy (surgery and radiation) and metastasis-directed stereotactic body radiation therapy (SBRT) to standard systemic therapy following standard HER2-targeted systemic therapy, compared to standard systemic therapy alone, in treating patients with HER2-positive stage IV breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or to a limited number of sites (oligometasta...
Source: ClinicalTrials.gov
Also in development
Drug Watch — recent news on Enhertu
- Breast Cancer FDA Approval Enhertu HER2 Positive Therapy - Specialty Pharmacy Continuum
- FDA approves Enhertu as neoadjuvant, adjuvant treatment for breast cancer - Medical Xpress
- AZN, Daiichi's Enhertu Gets Positive CHMP Opinion for Solid Tumors - Yahoo Finance
- Enhertu recommended for approval in the EU by CHMP for patients with previously treated HER2-positive metastatic solid tumours - AstraZeneca
- FDA Approves Metastatic Breast Cancer Drug Enhertu for Early-Stage Disease - Breast Cancer Research Foundation | BCRF
Sponsor Watch — recent news on Daiichi Sankyo
- Daiichi Sankyo Showcases Progress Across Industry-Leading Oncology Portfolio with Latest Research Updates at ASCO
- AZN, Daiichi's Enhertu Gets Positive CHMP Opinion for Solid Tumors
- Enhertu® Recommended for Approval in the EU by CHMP for Patients with Previously Treated HER2 Positive Metastatic Solid Tumors
- AZN, Daiichi's Enhertu Gets FDA Nod for Two New Breast Cancer Settings
- ENHERTU® (fam-trastuzumab deruxtecan-nxki) approved in the US for two new indications for patients with HER2-positive early breast cancer