US-based Nuvation Bio Inc. (NYSE: NUVB) has announced that the New Drug Application (NDA) for its investigational next-generation ROS1 tyrosine kinase inhibitor (TKI), taletrectinib, has been accepted for review by the US Food and Drug Administration (FDA) with priority review status. The filing seeks approval for taletrectinib to treat advanced ROS1+ non-small cell lung cancer (NSCLC), across all lines of therapy, following an Orphan Drug Designation (ODD) from the FDA. The FDA is expected to make its decision by June 23, 2025.
Co-Development and Marketing in Greater China
Taletrectinib, an oral next-generation ROS1 inhibitor discovered by AnHeart Therapeutics Inc., which was acquired by Nuvation earlier this year, is co-developed and commercialized in Greater China by China-based Innovent Biologics, Inc. (HKG: 1801) under a licensing deal established in June 2021. The drug was recently approved for marketing in China for the treatment of adult patients with ROS1 positive locally advanced or metastatic NSCLC that has progressed after prior ROS1-TKI therapy.
NDA Supported by TRUST-I and TRUST-II Study Results
The NDA for taletrectinib leverages combined results from the TRUST-I and TRUST-II studies. According to the summary analysis, taletrectinib demonstrated a reduction in tumor size in 89% of patients who had not received prior TKI treatment and 56% of patients who had received prior TKI treatment. Long-term follow-up data reveals that patients untreated with TKI have a median duration of remission (DOR) and a median progression-free survival (PFS) of up to 44 months and 46 months, respectively, following treatment with taletrectinib.-Fineline Info & Tech
