On Thursday, the U.S. Food and Drug Administration (FDA) approved Nuvation Bio Inc.’s (NYSE:NUVB) supplemental New Drug Application (sNDA) regarding its oncology drug IBTROZI (taletrectinib).
Following the announcement, the stock gained over 6%.
The approval comes four months ahead of the PDUFA date. The agency updated the label for the ROS1 inhibitor, which treats locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC), to showcase an extended median duration of response.
Extended Clinical Benefit And Safety
The revised label highlights a median duration of response of 49.7 months for TKI-naïve patients in the TRUST-I clinical trial.
The milestone represents over four years of enduring clinical benefits for patients.
Furthermore, the regulatory update confirms the drug’s safety profile remains intact. The expanded follow-up period revealed no new safety signals, and the safety sections of the drug’s labeling remain unchanged.
Long-Term Data And Global Progress
The supplemental application incorporates a 51-month median follow-up from the TRUST-I trial and adds 14 months of data from both the TRUST-I and TRUST-II studies as of August 2025.
The FDA originally granted IBTROZI full approval in June 2025. The drug also holds approvals in Japan and China, where Nippon Kayaku and Innovent Biologics market it, respectively.
Globally, the company and its partner Eisai continue to advance the therapy’s regulatory footprint.
The European Medicines Agency validated the Marketing Authorization Application (MAA) for taletrectinib in March 2026, followed by the United Kingdom’s Medicines and Healthcare products Regulatory Agency validating the MAA in June 2026.
Nuvation Bio Price Action
NUVB Price Action: Nuvation Bio shares were up 6.06% to $6.130 at the time of publication on Thursday, according to Benzinga Pro data.
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