Xcovery Holdings Receives US FDA Approval for Ensacove (Ensartinib) to Treat ALK-Positive Locally Advanced or Metastatic NSCLC
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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
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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)
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Ensartinib is an ALK tyrosine kinase inhibitor (TKI) developed by Xcovery & Betta Pharmaceuticals
Ref: Xcovery Holdings | Image: Xcovery Holdings
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A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies, FDA, EMA, and biosimilar approvals. He can be contacted at connect@pharmashots.com
