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FDA Approves Ensartinib (Ensacove) as First-Line Treatment for ALK-Positive NSCLC

NextEdge Admin

19 Dec 2024

2 min 15 sec

Xcovery Holdings, Inc., an oncology-focused pharmaceutical company, has announced FDA approval of ensartinib (Ensacove) for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). This milestone introduces a new first-line option for ALK-positive NSCLC patients, marking a significant advancement in precision medicine.

Ensartinib, an ALK tyrosine kinase inhibitor (TKI), was developed to enhance treatment outcomes for patients with ALK-positive NSCLC. The FDA approval is supported by results from the global Phase III eXalt3 clinical trial, where ensartinib demonstrated statistically significant improvements in progression-free survival (PFS) compared to crizotinib.

“This approval reflects our commitment to delivering innovative solutions for patients with ALK-positive NSCLC,” said Giovanni Selvaggi, Chief Medical Officer of Xcovery. “We thank the patients, physicians, and teams who contributed to this achievement.” Kevin Sang, CEO of Xcovery, highlighted the significance of this milestone in advancing targeted cancer therapies, reaffirming the company’s dedication to developing a robust pipeline of precision drugs for patients globally.

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

Xcovery focuses on advancing oncology therapeutics by developing small-molecule drugs that precisely target cancer mechanisms. With a strong pipeline targeting advanced solid tumors, the company remains committed to improving outcomes for patients, particularly in lung cancer.