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May 22, 2026
FDA approves AstraZeneca and Daiichi Sankyo's Datroway for first-line TNBC patients not eligible for PD-1/L1 inhibitors, based on Phase III TROPION-Breast02 data showing a 21% reduction in risk of death versus chemotherapy.
Mar 18, 2026
Agentic AI models are streamlining oncology clinical trial design and reducing phase II to III failure risk. Separately, Aethlon Medical progresses its Hemopurifier device trial in Australia with strong safety data and accelerated patient recruitment.
Mar 14, 2026
The ASCENT-04 trial showed sacituzumab govitecan plus pembrolizumab improved progression-free survival in PD-L1-positive TNBC without increased toxicity. Meanwhile, experts debate whether ADCs function as targeted therapy or advanced chemotherapy, with sequencing questions remaining unresolved.
Feb 20, 2026
Former Novartis executive John Tsai has been appointed global head of R&D at Daiichi Sankyo, replacing Ken Takeshita effective April 1. Tsai brings over 25 years of leadership experience in drug development.
Nov 04, 2025
Antibody-drug conjugates targeting TROP2 with topoisomerase I inhibitor payloads are currently marketed in breast and lung cancer, with over 100 such ADCs now in clinical trials for various malignancies including gastrointestinal tumors.
May 01, 2025
The FDA approved 46 novel drugs in 2025, down from 50 in 2024. Small molecules accounted for 31 approvals (67%), with oncology leading at nine approvals. Large molecules contributed 15 approvals (33%), spanning ADCs, bispecifics, and subcutaneous delivery innovations.
