BMS Reports the US FDA Acceptance of NDA and Granted Priority Review of Repotrectinib for ROS1-Positive Non-Small Cell Lung Cancer
Shots:
- The US FDA has accepted the NDA of repotrectinib (tyrosine kinase inhibitor) for ROS1+ LA or metastatic NSCLC & granted the Priority Review with an anticipated PDUFA date of Nov 2023
- The filling was based on the registrational P-I/II study (TRIDENT-1) evaluating the safety, tolerability, PK & anti-tumor activity of repotrectinib which showed high response rates & clinical durability of benefit in TKI-naïve and TKI-pretreated patients, incl. those with ROS1 resistance mutations. The safety profile was well-characterized & manageable
- The study continues to evaluate long-term outcomes & additional EPs across patient populations with ROS1+ LA or metastatic NSCLC & NTRK+ advanced solid tumors. The therapy received ODD from the US FDA in June 2017
Ref: BMS | Image: BMS
Related News:- Turning Point Presents Results of Repotrectinib in P-I/II TRIDENT-1 Study for the Treatment of Solid Tumors at AACR-NCI-EORTC 2021
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