Also known as: topoisomerase 1 inhibitor
The antibody-drug conjugate sacituzumab tirumotecan demonstrated significant survival benefits in pretreated EGFR-mutated NSCLC, with median overall survival of 20.0 months versus 13.5 months for docetaxel. The treatment also showed superior progression-free survival and objective response rates with a favorable safety profile compared to chemotherapy.
Genmab is moving GEN1106, a SLITRK6-targeting ADC acquired through its $1.8bn ProfoundBio takeover, into phase 1 trials despite several recent discontinuations and the 2017 failure of the only other similar project.
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.
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.
