The U.S. FDA has approved Nuvation Bio’s oral tyrosine kinase inhibitor, Ibtrozi, for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
Ibtrozi capsules are designed to address some of the outstanding challenges of treating ROS1+ NSCLC, a rare and aggressive form of lung cancer. The drug has demonstrated high response rates with durable benefit and intracranial activity and is generally well tolerated, providing a new treatment option for patients with advanced ROS1+ NSCLC.
The approval is supported by one of the largest global clinical trial programs in ROS1+ NSCLC to date, with over 300 patients enrolled in the pivotal TRUST-I and TRUST-II studies. In TRUST-I, Ibtrozi achieved a confirmed overall response rate of 90% in TKI-naïve patients. These findings were reinforced by the TRUST-II results, with a confirmed overall response rate of 85% in TKI-naïve patients.
In addition to the U.S., Ibtrozi is approved in China and additional global filings are underway.