Skip to main content
Premium Trial:

Request an Annual Quote

Xcovery Holdings Seeking FDA Approval for Frontline Ensartinib in ALK-Positive NSCLC

NEW YORK – Xcovery Holdings said Wednesday that it has filed an application with the US Food and Drug Administration seeking approval for its ALK inhibitor ensartinib for metastatic ALK-positive non-small cell lung cancer patients.

The application is based on the results of the randomized Phase III eXalt3 clinical trial, in which Xcovery pitted ensartinib against Pfizer's ALK inhibitor Xalkori (crizotinib).

The data, published in 2021, showed that patients with advanced ALK-positive NSCLC who had not previously received another ALK inhibitor lived for a median of 25.8 months without their cancers progressing when they received ensartinib versus a median of 12.7 months when they received Xalkori. Among ensartinib-treated patients with baseline brain metastases, the intracranial response rate was 64 percent versus 21 percent for those with baseline brain metastases who received Xalkori.

Xcovery believes ensartinib has advantages over already available ALK inhibitors due to the durable responses it has caused, including in the brain.

Palm Beach Gardens, Florida-based Xcovery is codeveloping ensartinib with Hangzhou, China-based Betta Pharmaceuticals. The drug has been approved in China as a first-line treatment for advanced ALK-positive NSCLC since 2022.

The FDA is expected to decide on whether to approve ensartinib in this setting by Dec. 28, 2024.