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Xcovery's Ensartinib Approved for First-Line ALK-Positive NSCLC in China

NEW YORK – Xcovery affiliate Betta Pharmaceuticals on Tuesday received approval from China's National Medical Products Administration for ensartinib as a first-line treatment for ALK-positive non-small cell lung cancer.

Ensartinib was previously approved in China as a second-line treatment for ALK-positive NSCLC patients. The drug was codeveloped by Xcovery, based in Palm Beach Gardens, Florida, and Betta, headquartered in Hangzhou, China.

The NMPA approved the latest indication based on results from a Phase III trial comparing ensartinib to Pfizer's Xalkori (crizotinib) in advanced ALK-positive NSCLC patients who had not received ALK inhibitor treatment. The data, published in JAMA Oncology in September, showed that ensartinib benefited patients more than Xalkori. The median progression-free survival in ensartinib-treated patients was 25.8 months versus 12.7 months in Xalkori-treated patients. The confirmed intracranial response rate for patients with brain metastases at baseline was 64 percent with ensartinib compared to 21 percent with Xalkori.

Xcovery is also studying ensartinib in ALK-positive NSCLC patients who have progressed on Xalkori, in patients with ROS1-positive NSCLC, and in patients with solid tumors enrolled in a basket trial.