Paolo Tarantino: Dato-DXd is now approved in Japan for HR+/HER2- MBC
Paolo Tarantino, Research fellow at Dana-Farber Cancer Institute and Harvard Medical School, shared a post by Raffaele Colombo, Associate Director of Medicinal Chemistry at Zymeworks, on X, adding:
“Dato-DXd is now approved in Japan for patients with HR+/HER2- MBC, based on the TROPION-Breast01 phase 3 trial.
Decision by the US FDA expected within one month (PDUFA date Jan 29, 2025).”
Quoting Raffaele Colombo’s post:
“Datopotamab deruxtecan (dato-DXd) approved in Japan for the treatment of patients with hormone receptor positive (HR+), HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) unresectable or recurrent breast cancer after prior chemotherapy.
Brand name: DATROWAY
Approval based on TROPION-Breast01 study.”
Authors: Aditya Bardia et al.
Paolo Tarantino, MD, is pursuing an advanced research fellowship at Dana-Farber Cancer Institute and Harvard Medical School, concurrently working towards a PhD in clinical research at the University of Milan. His research focuses on exploring the HER2 oncoprotein, investigating the emerging HER2-low subgroup of breast tumors, and developing novel antibody-drug conjugates targeting every subtype of breast cancer. With a publication record exceeding 50 papers on breast cancer, he is recognized as a leading expert in the field.
Raffaele Colombo is the Associate Director of Medicinal Chemistry at Zymeworks. His leadership and scientific acumen drive the discovery and optimization of novel drug candidates and advancing the treatment landscape for various diseases.
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