Xcovery Holdings Receives US FDA Approval for Ensacove (Ensartinib) to Treat ALK-Positive Locally Advanced or Metastatic NSCLC
Shots:
- Xcovery Holdings has received the US FDA’s approval for Ensacove (225mg, oral, QD) for ALK+, locally advanced or metastatic NSCLC in patients not previously treated with ALK-targeted therapy
- Approval was based on a global P-III (eXalt3) study assessing ensartinib vs crizotinib in 290 patients, demonstrating significantly improved PFS with mPFS of 25.8 vs 12.7mos. (1EP) & similar OS for both arms (2EP)
- Ensartinib is an ALK tyrosine kinase inhibitor (TKI) developed by Xcovery & Betta Pharmaceuticals
Ref: Businesswire | Image: Xcovery| Press Release
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