Daiichi Sankyo Introduces ENHERTU® Plus Pertuzumab as First-Line Treatment for HER2 Positive Metastatic Breast Cancer
Daiichi Sankyo has introduced ENHERTU® (fam-trastuzumab deruxtecan-nxki) in combination with pertuzumab as the first-line treatment for adults with unresectable or metastatic HER2 positive breast cancer, following U.S. FDA Breakthrough Therapy designation.
ENHERTU® is a HER2-directed antibody drug conjugate (ADC) developed using Daiichi Sankyo’s proprietary DXd technology. In combination with pertuzumab, it is designed to improve clinical outcomes by targeting HER2-expressing cancer cells while minimising damage to healthy tissues.
There have been limited advancements in first-line treatment for HER2 positive metastatic breast cancer in over a decade.
The FDA’s Breakthrough Therapy designation recognises the potential of ENHERTU® plus pertuzumab to significantly improve progression-free survival compared to current therapies. The designation was supported by data from the global Phase III DESTINY-Breast09 trial.
HER2 positive metastatic breast cancer affects 15% to 20% of patients with metastatic breast cancer and is associated with aggressive progression. Despite the availability of HER2-targeted therapies, many patients experience disease progression within two years, and one-third do not receive subsequent treatment due to poor health or death.
DESTINY-Breast09 involved 1,157 patients across multiple regions and compared ENHERTU® plus pertuzumab to standard THP therapy. The combination showed a median progression-free survival exceeding three years and a favourable safety profile.
ENHERTU® has now received nine Breakthrough Therapy designations, including five for metastatic breast cancer and others for HER2-positive or HER2-mutant solid tumours, underscoring its broad potential across oncology.
