Nuvation Bio Gets FDA Approval for Updated IBTROZI Label

08:01 AM EDT, 09/17/2026 (MT Newswires) -- Nuvation Bio (NUVB) said Thursday that the FDA approved its supplemental New Drug Application for IBTROZI (taletrectinib), a ROS1 inhibitor for locally advanced or metastatic ROS1-positive non-small cell lung cancer. The updated label includes a median duration of response of 49.7 months for TKI-naive patients in the TRUST-I study, based on a median follow-up of 51 months, it said. Nuvation said the update includes no changes to the safety sections or new safety signals. The company said it originally received FDA approval for IBTROZI in June 2025. The sNDA approval came four months ahead of its PDUFA date.