Nuvation Bio Reports the US FDA’s NDA Acceptance of Taletrectinib with Priority Review to Treat Advanced ROS1+ NSCLC
Shots:
- The US FDA has accepted NDA of taletrectinib (next-generation ROS1 TKI) and granted priority for treating advanced ROS1+ NSCLC, with the decision anticipated on Jun 23, 2025
- Submission was based on pooled data from ongoing P-II [TRUST-I (China) & TRUST-II (global)] studies assessing the safety & efficacy of taletrectinib monotx. for treating advanced NSCLC, with the data highlighted at ESMO 2024
- Pooled analysis showed cORR of 89% & intracranial cORR of 77% with mDoR of 44mos. & mPFS of 46mos. in TKI-naïve patients (n=160). In TKI-pretreated patients (n=113), cORR was 56% & 62% for G2032R mutations, with intracranial cORR of 66%, mDoR of 17mos. & mPFS of 10mos.
Ref: Nuvation Bio | Image: Nuvation Bio
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
