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FDA Approves New Drug Application (NDA) for Ensartinib

Thursday, March 14, 2024

Xcovery Holdings, Inc., a pharmaceutical company specializing in oncology, has announced today that the U.S. Food and Drug Administration (FDA) has officially accepted the New Drug Application (NDA) for ensartinib. This drug is an Anaplastic Lymphoma Kinase (ALK) inhibitor intended for treating adult patients with metastatic ALK-positive non-small cell lung cancer (NSCLC). The NDA submission is supported by data from the eXalt3 study, a randomized global phase III trial designed to evaluate ensartinib's efficacy and safety compared to crizotinib in first-line treatment for ALK-positive NSCLC. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of December 28, 2024, and has designated the application for Standard Review.

Xcovery, emphasized the significance of this milestone, stating, "The FDA’s acceptance of this NDA represents a pivotal moment for Xcovery as we endeavor to offer ensartinib as an innovative first-line treatment option for ALK-positive NSCLC patients." Dr. Selvaggi also reiterated the commitment to collaborating closely with the FDA during the review process. He credited the achievement to the patient-centric approach of the company and acknowledged the dedication and expertise of the entire Xcovery team, along with the support of patients, their families, and clinical investigators globally.

Ensartinib, developed jointly by Xcovery and Betta Pharmaceuticals, is a next-generation ALK inhibitor. Clinical trials have shown promising results, including robust and lasting responses in ALK-positive NSCLC patients, both systemically and in the brain. The drug's safety profile has been extensively studied and deemed manageable. 



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