BMS Reports the US FDA’s Accelerated Approval of Augtyro to Treat Locally Advanced or Metastatic Solid Tumors
Shots:
- The approval of Augtyro (160mg, oral, QD for 14 days then BID until progression) was based on P-I/II (TRIDENT-1) study of its safety, tolerability, PK & anti-tumor activity in adults & pediatrics (≥12yrs.) with NTRK+, locally advanced/metastatic solid tumors. Full approval depends upon confirmatory studies
- In TKI-naïve patients (n=40) at a median follow-up of 17.8mos., 58% had cORR (PR in 43% & CR in 15%); 83% remained in response at 1yr. with mDoR not attained & intercranial responses in 2/2 of them
- In TKI-pretreated patients (n=48) at a median follow-up of 20.1mos., 50% had cORR (all had PR); 42% remained in response at 1yr. with mDoR of 9.9mos. & intercranial responses in 3/3 of them. Safety & efficacy in <12yrs. old patients are not evaluated
Ref: BMS | Image: BMS
Related News:- Zai Lab’s Augtyro Receives the NMPA’s Approval to Treat Non-Small-Cell Lung Cancer (NSCLC)
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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.
