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  • NDA 218171 NDA APPROVAL - accessdata. fda. gov
    Please refer to your new drug application (NDA) dated and received December 28, 2023, and your amendments, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for ENSACOVE (ensartinib) capsules This NDA provides for the use of ENSACOVE (ensartinib) capsules for the treatment of
  • Ensacove (ensartinib) FDA Approval History - Drugs. com
    FDA approval of Ensacove was supported by results of the eXALT3 (NCT02767804) trial comparing ensartinib to crizotinib in patients with ALK-positive NSCLC Ensartinib demonstrated a statistically significant progression-free survival (PFS) improvement compared to crizotinib, with a median PFS of 25 8 months in the ensartinib arm and 12 7 months
  • FDA Accepts NDA for Ensartinib in Metastatic ALK-Positive NSCLC
    “The FDA’s acceptance of this NDA represents a key milestone for Xcovery in its mission to bring ensartinib as a novel and distinct first-line therapeutic option to [patients with] ALK-positive NSCLC,” Giovanni Selvaggi, MD, chief medical officer at Xcovery, stated in the press release 1 “We will continue to work closely with the
  • FDA Approves Ensartinib in ALK-Positive NSCLC
    The FDA has granted ensartinib approval for adult patients with ALK-positive non–small cell lung cancer Ensartinib has received FDA approval for the first-line treatment of anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non–small cell lung cancer (NSCLC) Ensartinib is
  • FDA Approves Ensartinib for Locally Advanced or Metastatic . . .
    The FDA has approved ensartinib (Ensacove) for the treatment of adult patients with ALK-positive locally advanced or metastatic non–small cell lung cancer (NSCLC) who have not previously
  • FDA Accepts Ensartinib Application in Non-Small Cell Lung Cancer
    Patients are randomized to receive 225 mg of ensartinib daily or placebo The study began in May 2022 and has an anticipated completion date of July 2025 REFERENCES: 1 U S Food and Drug Administration (FDA) has accepted the new drug application (NDA) for ensartinib News release Xcovery Holdings, Inc March 13, 2024 Accessed March 13, 2024
  • Ensartinib Receives FDA Approval for ALK-Positive Locally . . .
    Manufactured by Xcovery Holdings Inc and Betta Pharmaceuticals, ensartinib’s new drug application was accepted by the FDA in March 2024 2 The approval is based on the results from eXalt3
  • HIGHLIGHTS OF PRESCRIBING INFORMATION Visual Disturbances . . .
    (ensartinib) capsules, for oral use Initial U S Approval: 2024 -----INDICATIONS AND USAGE-----ENSACOVE is a kinase inhibitor indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or





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