Xcovery Holdings, Inc., announced that the FDA accepted the New Drug Application (NDA) for ensartinib, an Anaplastic Lymphoma Kinase (ALK) inhibitor for the treatment of adult patients with metastatic ALK-positive non-small cell lung cancer (NSCLC). The filing is based on the results of the eXalt3, a randomized global phase III study designed to evaluate the efficacy and safety of ensartinib vs crizotinib in the first-line treatment of ALK-positive NSCLC. The FDA granted the application Standard Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 28, 2024.
“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 ALK-positive NSCLC patients,” said Giovanni Selvaggi, M.D., Chief Medical Officer of Xcovery. “We will continue to work closely with the agency during the review period. This achievement is a testament to our patient-centric vision and has been made possible by the dedication and skills of the entire Xcovery team and stakeholders, with the constant support of the patients, their families and investigators in our clinical trials globally.”
Ensartinib is a next generation ALK inhibitor jointly developed by Xcovery and Betta Pharmaceuticals. In the clinical trials, the drug has demonstrated robust and durable responses in ALK-positive NSCLC patients (both systemically and in the brain), with an extensively studied and well manageable safety profile. The results of the eXalt3 were originally published in JAMA Oncology in September 2021.
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