Nuvation Bio said the U.S. Food and Drug Administration approved a supplemental New Drug Application for IBTROZI (taletrectinib), an oral, CNS-active ROS1 inhibitor for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer. The updated label records a median duration of response of 49.7 months in TKI-naïve patients in the TRUST-I study, representing more than four years of sustained response. The approval came four months ahead of the PDUFA date and incorporates a median follow-up of 51 months for TRUST-I patients, along with 14 additional months of data from the pivotal TRUST-I and TRUST-II studies through an August 2025 cutoff. Nuvation Bio said the longer follow-up prompted no changes to the safety sections and identified no new safety signals. The data were presented at the 2026 American Association for Cancer Research annual meeting and published simultaneously in the Journal of Clinical Oncology. Nuvation Bio shares rose 6.06% to $6.130 at the time of publication, according to Benzinga Pro data.