On December 18, 2024, the Food and Drug Administration approved ensartinib (Ensacove, Xcovery Holdings, Inc.) for adult patients with anaplastic lymphoma kinase (ALK)-positive locally...

On December 18, 2024, The FDA has approved ensartinib for the treatment of ALK-positive, locally advanced, or metastatic non-small cell lung cancer (NSCLC).

“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.

Dec 19, 2024 · Ensartinib's approval is based on its enhanced efficacy and safety profile in patients previously treated with an ALK-inhibitor. The indication is for patients with locally advanced or …

Dec 18, 2024 · Ensartinib received FDA approval for ALK-positive NSCLC patients without prior ALK inhibitor treatment, based on the eXALT3 trial results. The eXALT3 trial showed ensartinib …

Dec 18, 2024 · FDA Approves Ensartinib for ALK+ Advanced NSCLC - Medscape - December 18, 2024. The next-generation ALK-inhibitor more than doubled progression-free survival compared with …

Dec 28, 2024 · FDA approval of Ensacove was supported by results of the eXALT3 (NCT02767804) trial comparing ensartinib to crizotinib in patients with ALK-positive NSCLC.

Dec 19, 2024 · On Dec. 18, the U.S. Food and Drug Administration (FDA) approved ensartinib (Ensacove) for adults with anaplastic lymphoma kinase (ALK)-mutated locally advanced or …

Dec 19, 2024 · The FDA has approved ensartinib in adult patients with anaplastic lymphoma kinase (ALK)–positive locally advanced or metastatic non–small cell lung cancer (NSCLC) naive to ALK …