Nuvation Bio Shares Rise After FDA Updates Lung Cancer Drug Label with Long-Term Efficacy Data

Shares of Nuvation Bio Inc. (NYSE:NUVB) rose 5.5% in Thursday trading after the U.S. Food and Drug Administration (FDA) approved a significant update to the label for its lung cancer therapy, IBTROZI (taletrectinib).

FDA Approves Label Update

The FDA approved a supplemental New Drug Application for IBTROZI, a ROS1 inhibitor used to treat adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). The approval, which came four months ahead of the scheduled Prescription Drug User Fee Act (PDUFA) date, allows for the inclusion of new long-term efficacy data on the drug's official prescribing information.

The updated label now reflects a median duration of response of 49.7 months for patients who had not previously been treated with a tyrosine kinase inhibitor (TKI-naïve). This new data point, sourced from the TRUST-I clinical trial, demonstrates a sustained clinical benefit lasting more than four years for this patient group.

Clinical Data and Safety Profile

The supplemental application was supported by an updated analysis with a median follow-up of 51 months for patients in the TRUST-I study. It also incorporated an additional 14 months of data from both the TRUST-I and TRUST-II studies, based on an August 2025 data cutoff.

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Importantly, the FDA's approval included no changes to the safety sections of the drug's label. The company noted that no new safety signals were identified with the longer follow-up, reinforcing the drug's established safety profile.

Global Regulatory Context

This label update follows the FDA's full approval of IBTROZI in June 2025 for treating ROS1-positive NSCLC across different lines of therapy. The drug is also on the market in other key regions:

• In Japan, it is marketed by Nippon Kayaku.
• In China, it is marketed by Innovent Biologics under the brand name DOVBLERON.

Nuvation Bio and its partner Eisai are also seeking approval in Europe, where the European Medicines Agency (EMA) validated their Marketing Authorisation Application in March 2026. A similar application was validated in the United Kingdom by the Medicines and Healthcare products Regulatory Agency (MHRA) in June 2026.