Raffaele Colombo, Associate Director of Medicinal Chemistry at Zymeworks, shared a post on X:
“China is the first country to conditionally approve T-DXd in curative-intent early breast cancer setting!
Approval based on the DESTINY-Breast11 phase 3 trial, which showed an improvement in pCR rate.
FDA PDUFA target date for regulatory decision is 18 May 2026!”
Abi Siva, Associate Professor and Director of Medical Oncology at MUSC Health Hematology Oncology at Hollings Cancer Center, shared Raffaele Colombo’s post, adding:
“This is great news! Hopefully the FDA Oncology will follow soon.
I’ve been able to get it without major insurance issues since it’s already listed in NCCN.”
