Jame Abraham, Chairman and Professor at the Department of Hematology and Medical Oncology at Cleveland Clinic, shared a post on LinkedIn:
“FDA Approval Today – Practice-Changing Advance in HER2-Positive Metastatic Breast Cancer.
Fam-trastuzumab deruxtecan-nxki (T-DXd, Enhertu) + pertuzumab (Perjeta) is now FDA-approved for the first-line treatment of unresectable or metastatic HER2-positive breast cancer, based on the pivotal DESTINY-Breast09 trial.
- Median PFS: ~40.7 months vs ~26.9 months with standard taxane + trastuzumab + pertuzumab
- Higher response and complete response rates
- Signals a major shift from chemotherapy-based first-line regimens to ADC-based strategies
This approval represents a new era in HER2-positive disease, redefining first-line therapy while underscoring the importance of vigilant monitoring for ADC-associated toxicities, including ILD/pneumonitis.
A new first-line standard of care.”
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