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【FDA Approval Alert】Nuvation Bio’s taletrectinib (Ibtrozi) Approved for ROS1-Positive Non-Small Cell Lung Cancer (June 11, 2025)
On June 11, 2025, the U.S. FDA approved taletrectinib (Ibtrozi) for adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). This kinase inhibitor was approved based on TRUST-I (NCT04395677) and TRUST-II (NCT04919811) trials.
Disease Overview: ROS1-Positive Non-Small Cell Lung Cancer
ROS1-positive NSCLC is a molecular subtype of lung cancer characterized by ROS1 gene fusions, leading to abnormal kinase activity. Targeted therapies against ROS1 have demonstrated clinical benefit.
Treatment Summary
- Drug Name: taletrectinib (Ibtrozi)
- Company: Nuvation Bio Inc.
- Approval Date: June 11, 2025
- Indication: ROS1-positive locally advanced or metastatic NSCLC
- Mechanism of Action: ROS1 kinase inhibition
- Pivotal Trials: TRUST-I (NCT04395677), TRUST-II (NCT04919811)
- Key Efficacy:
- TKI-naive: ORR 85–90%, DOR ≥12 months in 63–72% of responders
- TKI-pretreated: ORR 52–62%, DOR ≥6 months in 74–83% of responders
Patient-Friendly Summary
Ibtrozi is an oral therapy targeting ROS1 gene alterations, offering high response rates regardless of prior treatment history. It is administered on an empty stomach.
M&A Information
- Subsidiary: Not applicable (Nuvation Bio in-house development)
- Acquisition Date: Not applicable
- Development Stage at Acquisition: Not applicable
- Investor Information: Public Investors (NYSE: NUVB)
Source
This approval information is based on data from Drugs@FDA (U.S. FDA) and AACR releases.
