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
Enhertu treats HER2-positive breast cancer, a form of the disease where tumors overproduce a protein called HER2 that drives aggressive growth. The drug is an antibody attached to chemotherapy that delivers its payload directly into HER2-positive cancer cells. This targeted approach aims to destroy tumors more precisely while potentially limiting damage to healthy tissue.
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
- AZN Receives Positive EU Recommendation for Enhertu in Breast Ca - GuruFocus
- EU panel endorses label upgrades for Trodelvy, Enhertu in 1L breast cancer - FirstWord Pharma
- Enhertu® Plus Pertuzumab Recommended for Approval in the EU by CHMP as First-Line Treatment for Patients with HER2 Positive Metastatic Breast Cancer - Business Wire
- CHMP Backs Enhertu, Pertuzumab for HER2+ Breast Cancer - Mirage News
- Queue for life-extending breast cancer drug in Trafalgar Square as campaigners demand Enhertu - Breast Cancer Now
Sponsor Watch — recent news on Daiichi Sankyo
- Enhertu® Plus Pertuzumab Recommended for Approval in the EU by CHMP as First-Line Treatment for Patients with HER2 Positive Metastatic Breast Cancer
- AstraZeneca's Enhertu Wins EU Nod for HER2-Positive Solid Tumors (Revised)
- AstraZeneca's Enhertu Wins EU Nod for HER2-Positive Solid Tumors
- Enhertu® Approved in the EU as First Tumor Agnostic HER2 Directed Therapy and Antibody Drug Conjugate for Patients with Previously Treated HER2 Positive Metastatic Solid Tumors
- AZN, Daiichi's Enhertu Gets Positive CHMP Opinion for Solid Tumors