JIDEYTRO (zidesamtinib)
ROS1-positive non-small cell lung cancer · Adults with locally advanced or metastatic ROS1-positive NSCLC who received at least one prior ROS1 tyrosine kinase inhibitor
NUVL · Nuvalent
Regulatory designations
Full timeline
4 milestonesFDA approved JIDEYTRO
FDA approved JIDEYTRO for adults with locally advanced or metastatic ROS1-positive NSCLC after at least one prior ROS1 TKI. The action occurred before the September 18 PDUFA date.
FDA — Approval of zidesamtinib↗FDA accepted the NDA
FDA accepted the zidesamtinib NDA for TKI-pretreated advanced ROS1-positive NSCLC and assigned a September 18, 2026 PDUFA target action date.
Nuvalent — FDA acceptance of the zidesamtinib NDA↗Pivotal ARROS-1 data were presented
Nuvalent presented the registrational ARROS-1 efficacy and safety data for zidesamtinib in TKI-pretreated advanced ROS1-positive NSCLC at the World Conference on Lung Cancer.
Nuvalent — Pivotal ARROS-1 presentation↗Phase 1/2 ARROS-1 study started
ARROS-1 began enrolling patients with ROS1-positive advanced solid tumors to characterize zidesamtinib activity and safety, generating the pivotal cohort used for the NDA.
ClinicalTrials.gov — ARROS-1 study record (NCT05118789)↗Related News
No related news available.