FDA Approval of Ensartinib for ALK-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

MIAMI--(BUSINESS WIRE)--Xcovery Holdings, Inc., an oncology focused pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved ensartinib (Ensacove, Xcovery Holdings, Inc.) for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). This approval marks an important advancement in providing a new first line option for patients with ALK-positive NSCLC.

Ensartinib is an ALK tyrosine kinase inhibitor (TKI) designed to improve outcomes for patients with ALK-positive NSCLC. The FDA approval is based on data from the pivotal global Phase III eXalt3 clinical trial, in which ensartinib demonstrated statistically significant improvements in progression-free survival (PFS) over crizotinib.

“The approval of Ensartinib by FDA brings another new medicine to patients battling ALK-positive NSCLC, expanding the options to optimize treatment in the first-line setting. This result could not have been achieved without the dedication of our team members and the support of patients, physicians, and all stakeholders involved in the clinical development of Ensartinib,” said Giovanni Selvaggi, Chief Medical Officer of Xcovery.

“FDA approval of Ensartinib represents a significant milestone in Xcovery’s mission to advance precision medicine for patients with cancer,” said Kevin Sang, CEO of Xcovery. “In addition to Ensartinib, we are continuing our efforts in developing more pipeline targeted drugs for patients worldwide.”

About Ensartinib

Ensartinib is a next generation ALK inhibitor jointly developed by Xcovery and Betta Pharmaceuticals. It is indicated for the treatment of adult patients with ALK-positive locally advanced or metastatic NSCLC.

About Xcovery

Xcovery is a pharmaceutical company working to improve the lives of patients with cancer by discovering and developing small molecules that precisely target cancer growth mechanisms. Xcovery is developing a pipeline of drugs targeting a wide range of advanced solid tumors with a focus on lung cancer.

Forward‐Looking Statements

This press release contains forward‐looking statements that are based on company management’s current beliefs and expectations and are subject to currently unknown information, risks and circumstances and actual results may vary from what is being currently projected.