Nuvation Bio Gains Approval for IBTROZI™ (taletrectinib) to Treat Advanced ROS1-Positive Lung Cancer
Thursday, June 12, 2025
Nuvation Bio has received approval from the U.S. Food and Drug Administration (FDA) for IBTROZI™ (taletrectinib), a next-generation oral therapy for adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
ROS1-positive NSCLC represents a small but aggressive subset of lung cancer cases, making up around 2% of all NSCLC diagnoses in the U.S.—approximately 3,000 new cases per year. The condition is more common in younger patients and those with no history of smoking. Brain metastases are a significant concern, affecting around one-third of newly diagnosed metastatic cases and over half of previously treated patients.
IBTROZI was generally well tolerated during clinical evaluation. Common side effects (≥20%) included diarrhoea, nausea, vomiting, dizziness, rash, constipation, and fatigue. Liver enzyme elevations and QT interval prolongation were observed but manageable with standard care. Treatment discontinuation due to side effects was reported in 7% of cases. The recommended dose is 600 mg taken orally once daily.
IBTROZI is a highly selective tyrosine kinase inhibitor (TKI) developed to overcome challenges in treating ROS1-positive NSCLC.
The approval is based on data from two pivotal global clinical trials—TRUST-I and TRUST-II—comprising over 300 patients. In TKI-naïve patients, IBTROZI demonstrated a confirmed overall response rate (cORR) of 90% in TRUST-I and 85% in TRUST-II. The duration of response remained ongoing in both studies at the time of analysis, with TRUST-I showing responses lasting up to 46.9 months. In patients previously treated with a ROS1 TKI, the cORR ranged from 52% to 62%, with responses lasting up to 19.4 months.
The drug has also shown the ability to cross the blood-brain barrier, addressing brain metastases, a frequent complication in this patient population. Intracranial responses were recorded in 73% of TKI-naïve and 63% of TKI-pretreated patients with measurable brain lesions.
With regulatory approvals now secured in both the United States and China, Nuvation Bio is moving forward with additional submissions worldwide, aiming to broaden access to this new treatment option for patients with advanced ROS1-positive NSCLC.
Source: nuvationbio.com
