FDA Approves Nuvation Bio’s Ibtrozi for Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer

 



The U.S. Food and Drug Administration (FDA) has approved Nuvation Bio's oral medication, Ibtrozi (taletrectinib), for the treatment of patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). This approval was announced on June 11, 2025, following a Priority Review designation by the FDA, with a Prescription Drug User Fee Act (PDUFA) goal date of June 23, 2025

What Is ROS1-Positive NSCLC?

ROS1-positive NSCLC is a rare and aggressive form of lung cancer characterized by genetic alterations in the ROS1 gene. It accounts for approximately 2% of all NSCLC cases, translating to about 3,000 new diagnoses annually in the United States. Patients with this condition are typically younger and often have little to no history of smoking .

Clinical Trial Findings

The FDA's approval of Ibtrozi was based on data from two pivotal Phase 2 clinical trials, TRUST-I and TRUST-II. These studies demonstrated that Ibtrozi achieved high response rates and durable benefits in patients with advanced ROS1-positive NSCLC. Notably, in treatment-naïve patients, 89% experienced tumor shrinkage, with a median duration of response of 44 months and a median progression-free survival of 46 months. Even among patients previously treated with ROS1 tyrosine kinase inhibitors (TKIs), 56% showed tumor shrinkage

Pricing and Availability

Ibtrozi is priced at $29,488 per month. The medication is expected to become available in the United States in the coming weeks .

Competitive Landscape

Ibtrozi joins a growing list of FDA-approved therapies for ROS1-positive NSCLC, including Bristol-Myers Squibb's Augtyro (repotrectinib), Pfizer's Xalkori (crizotinib), and Roche's Rozlytrek (entrectinib). Each of these treatments offers unique mechanisms of action and may be suitable for different patient populations .

Global Approvals

Beyond the United States, Ibtrozi has also received regulatory approval in other markets. In January 2025, China's National Medical Products Administration approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC. In this region, the drug is marketed under the brand name DOVBLERON® by Innovent Biologics

#LungCancer
#NSCLC
#ROS1Positive
#CancerAwareness
#LungCancerAwareness
#TargetedTherapy
#CancerResearch
#Oncology
#PrecisionMedicine
#CancerTreatment

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