NEW YORK – The US Food and Drug Administration on Wednesday approved Xcovery's Ensacove (ensartinib) as a treatment for patients with ALK-positive locally advanced or metastatic non-small cell lung cancer who have not previously received an ALK inhibitor.
The agency based its decision on the Phase III eXalt3 trial in which researchers compared Ensacove to Pfizer's ALK inhibitor Xalkori (crizotinib) in 290 patients who have received up to one prior chemotherapy regimen and have not received an ALK inhibitor. Patients on Ensacove lived a median of 25.8 months compared with 12.7 months for patients on Xalkori without disease progression or death. There was no statistically significant difference in overall survival between the two groups. The most common adverse reactions included rash, musculoskeletal pain, nausea, fever, and fatigue.
Palm Beach Gardens, Florida-based Xcovery is codeveloping Ensacove with Hangzhou, China-based Betta Pharmaceuticals. Ensacove is already approved in China as a first-line treatment for ALK-positive NSCLC.