Enhertu is the brand name of trastuzumab deruxtecan, an antibody-drug conjugate combining trastuzumab with a topoisomerase I inhibitor payload. It is used in HER2-expressing cancers including breast, NSCLC, and gastric/GEJ adenocarcinoma settings. It has approvals in the U.S., Japan, EU, and other regions with multiple later indication expansions.
The global antibody drug conjugate market is calculated at USD 14.76 billion in 2026 and is expected to reach USD 32.66 billion by 2035. North America held a 53% share in 2025, while Asia Pacific is projected to grow fastest.
ALX Oncology has multiple 2026 catalysts for Evorpacept and ALX2004. Interim ASPEN-09 data are expected in Q3 2026, while an initial safety update from the phase 1 ALX2004 trial is expected in 1H 2026.
Over 20 pharmaceutical companies are developing therapies for HER2-positive gastric cancer, with multiple Phase III trials launched in March 2026 testing novel combination treatments for advanced disease.
Exploratory analysis from a phase 1/2 trial shows CD47 expression levels predict response to evorpacept plus zanidatamab in heavily pretreated HER2-positive metastatic breast cancer patients, supporting biomarker-driven patient selection.
The US FDA granted priority review and the European Medicines Agency validated applications for Enhertu as post-neoadjuvant treatment for HER2-positive early breast cancer, based on Phase III trial data showing 53% reduction in recurrence risk.
AstraZeneca announced a $15 billion investment in Chinese R&D facilities through 2030, elevating China to a global innovation hub, while former China chief Leon Wang faces charges for unlawful data collection, illegal trade, and medical insurance fraud.
ALX Oncology reported fourth quarter and full year 2025 financial results, highlighting validation of CD47 as a predictive biomarker for evorpacept in HER2-positive cancers and progress in its ALX2004 EGFR-targeted ADC program.
AstraZeneca's CALQUENCE received FDA approval as the first all-oral, fixed-duration regimen for chronic lymphocytic leukemia, while the EMA validated the marketing authorization application for ENHERTU in HER2-positive breast cancer treatment.
Enhertu combined with pertuzumab received FDA approval for first-line treatment of HER2-positive metastatic breast cancer, marking the first new treatment in a decade. Real-world data show trastuzumab deruxtecan efficacy is consistent across patient subgroups.
Former Novartis executive John Tsai has been appointed global head of R&D at Daiichi Sankyo, replacing Ken Takeshita effective April 1. Tsai brings over 25 years of leadership experience in drug development.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT06610825 |
Castrate Resistant Prostate Cancer Enhertu Therapy |
RECRUITING | PHASE2 |
