Nuvation Bio wins FDA nod to update IBTROZI label with 49.7-month response duration in TRUST-I study

• 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.
• 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.
• The action strengthens IBTROZI’s commercial positioning by adding durability evidence directly to the FDA label.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Nuvation Bio Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: 202609170730PR_NEWS_USPR_____NY50012) on September 17, 2026, and is solely responsible for the information contained therein.