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Nuvation Bio Announces FDA Acceptance of Supplemental New Drug Application for IBTROZI® (taletrectinib) with Updated Duration of Response in Advanced ROS1-Positive Non-Small Cell Lung Cancer
Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, announced today that the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) with updated data for IBTROZI® (taletrectinib) in both TKI-naïve and TKI-pretreated advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) with a target action date of January 4, 2027.
About this update from Nuvation Bio Inc.
[{"type":"text","content":"Application includes updated TRUST-I TKI-naïve median duration of response (mDOR) and median progression-free survival (mPFS) of more than 4 years, as well as TRUST-II TKI-pretreated mDOR of nearly 20 months ","length":207,"tagName":"p","attribs":{}},{"type":"text","content":"FDA has assigned a target action date of January 4, 2027","length":56,"tagName":"p","attribs":{}},{"type":"text","content":"NEW YORK, May 6, 2026 /PRNewswire/ -- Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, announced today that the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) with updated data for IBTROZI® (taletrectinib) in both TKI-naïve and TKI-pretreated advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) with a target action date of January 4, 2027.","length":485,"tagName":"p"},{"type":"image","alt":"Nuvation Bio logo (PRNewsfoto/Nuvation Bio Inc.)","displaySize":"","headline":null,"caption":"Nuvation Bio logo (PRNewsfoto/Nuvation Bio Inc.)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":67,"url":"https://media.zenfs.com/en/prnewswire.com/eb40545e5f1eb1361b80045a4fef7988"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/VSdvqELO80DAUOQ0oaqyVQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTExOA--/https://media.zenfs.com/en/prnewswire.com/eb40545e5f1eb1361b80045a4fef7988","width":400,"height":67}},"href":"https://mma.prnewswire.com/media/2924210/Nuvation_Bio_Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"The submission, which fulfills an FDA post-marketing commitment and is intended to update the efficacy information provided in the IBTROZI label, includes an additional 10 months of data from the pivotal TRUST-I and TRUST-II studies as of an August 2025 data cutoff, further validating the overall clinical profile with long-term follow-up. As of this data cutoff, IBTROZI demonstrated median duration of response (mDOR) of 49.7 months and median progression-free survival (mPFS) of 49.6 months in TKI-naïve patients in TRUST-I, reflecting more than four years of sustained clinical benefit, and mDOR of 19.4 months in TKI-pretreated patients in TRUST-II. In the TRUST-II study, the mDOR had not yet been reached in TKI-naïve patients at the time of the data ...