Sarah Sammons: Major FDA News for Early Stage HER2+ Breast Cancer
Sarah Sammons/LinkedIn

Sarah Sammons: Major FDA News for Early Stage HER2+ Breast Cancer

Sarah Sammons, Breast Medical Oncologist and Senior Physician at Dana-Farber’s Breast Oncology Center, shared a post on LinkedIn:

“Major FDA news today for early-stage HER2+ breast cancer. T-DXd approved for two separate indications: neoadjuvant Stage II/III disease (T-DXd x4 followed by THP x4), and adjuvant treatment for residual invasive disease after neoadjuvant HER2-targeted therapy.

The data are striking. DESTINY-Breast11: pCR 67.3% vs 56.3% with ddAC-THP (p=0.003). DESTINY-Breast05: 3-year IDFS 92.4% vs 83.7% with T-DM1, HR 0.47 (95% CI 0.34-0.66, p<0.0001).

But the real work is just beginning.

Not every high-risk patient needs T-DXd upfront. Our challenge as oncologists is figuring out who needs what. Biomarker-driven selection, ctDNA, pCR response – these questions have to follow. Escalation and de-escalation must evolve together.”

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