Nuvation Bio Scores First FDA Approval for Oral Lung Cancer Drug Ibtrozi

The U.S. FDA has approved Nuvation Bio's IBTROZI (taletrectinib), a next-generation oral ROS1 tyrosine kinase inhibitor, for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC)234.

IBTROZI has demonstrated high, durable response rates and intracranial activity in clinical trials, providing a new treatment option for advanced ROS1+ NSCLC patients2.

The approval was supported by the robust TRUST clinical program, which established the drug's efficacy and a favorable, consistent safety profile—represented by one of the largest safety datasets in ROS1+ NSCLC2.

IBTROZI will compete with existing drugs from Pfizer (Xalkori), Roche (Rozlytrek), and Bristol Myers Squibb (Augtyro) in the ROS1-positive NSCLC market1.

Nuvation Bio acquired rights to Ibtrozi outside of China, Japan, and Korea after acquiring AnHeart Therapeutics in 20241.

The FDA decision follows a Priority Review process, reflecting the urgent clinical need and promising potential of IBTROZI in this patient population2.

Sources:

1. https://www.fiercepharma.com/pharma/david-hung-nuvation-bio-wins-fda-approval-ibtrozi-challenge-pfizer-bms-and-roche-lung-cancer

2. https://investors.nuvationbio.com/news/news-details/2025/U-S--Food-and-Drug-Administration-Approves-Nuvation-Bios-IBTROZI-taletrectinib-a-Next-Generation-Oral-Treatment-for-Advanced-ROS1-Positive-Non-Small-Cell-Lung-Cancer/default.aspx

3. https://www.biopharmadive.com/news/nuvation-ibtrozi-fda-approval-ros1-lung-cancer/750499/

4. https://www.tabletscapsules.com/3639-News/619828-Nuvation-Wins-FDA-Approval-for-Oral-ROS1-Lung-Cancer-Drug/