Nuvation Bio wins FDA nod to update IBTROZI label with 49.7-month response duration in TRUST-I study
NUVB•Commercial significance
The action strengthens IBTROZI’s commercial positioning by adding durability evidence directly to the FDA label.
FDA clears label update for IBTROZI
Nuvation Bio secured FDA clearance for a supplemental filing updating IBTROZI’s label in ROS1-positive advanced non-small cell lung cancer.
The revision incorporates longer follow-up from the TRUST-I study, showing responses lasted longer without detailing technical endpoints.
Extended follow-up shows no new safety concerns
No new safety concerns emerged with extended observation, supporting continued use across treatment settings.
Longer-term TRUST program results were already presented at AACR 2026, with publication in the Journal of Clinical Oncology.
