In early March, the US Food and Drug Administration accepted a New Drug Application (NDA) for ensartinib, an ALK inhibitor for the treatment of patients with metastatic ALK-positive non-small cell lung cancer (NSCLC).1
The application was based on the results of the eXalt3 trial, a global, randomized phase III study designed to evaluate the efficacy and safety of ensartinib compared to crizotinib in the first-line treatment of ALK-positive NSCLC. The FDA set a goal date of December 28, 2024, for reviewing the application.1
Ensartinib is a next generation ALK inhibitor. In the clinical trials, the drug demonstrated robust and durable systemic and CNS responses in ALK-positive NSCLC patients, with a manageable safety profile. The results of the eXalt3 trial were originally published in September 2021.2
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.
- 2. Horn L, Wang Z, Wu G, et al. Ensartinib vs Crizotinib for Patients With Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer: A Randomized Clinical Trial. JAMA Oncol. 2021;7(11):1617-1625. doi:10.1001/jamaoncol.2021.3523
