Also known as: ROS1
Pfizer's ELREXFIO significantly delayed disease progression in a Phase 3 trial for multiple myeloma, outperforming a standard regimen and strengthening the case for earlier use. Separately, Pfizer completed a real-world study of its lung cancer drug lorlatinib in ROS1-positive NSCLC patients.
Nuvalent provided updates on regulatory milestones for its lead oncology programs, including FDA acceptance of the zidesamtinib NDA with a September PDUFA date and plans to submit an NVL-655 NDA in the first half of 2026.
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.
