FDA Approves Ensartinib for ALK+ Advanced NSCLC

The US Food and Drug Administration (FDA) has approved ensartinib (Ensacove, Xcovery Holdings, Inc.) for the treatment of adults with ALK-positive locally advanced or metastatic non-small cell lung cancer who have not previously received an ALK inhibitor.

Approval for the new ALK-inhibitor was based on findings from the randomized, open-label, active-controlled eXalt3 trial, which found patients receiving ensartinib had two-fold longer progression-free survival (PFS) compared with those who received crizotinib, the current first-line standard-of-care in this patient population, according to the FDA approval notice. 

In the trial, 290 patients were randomized 1:1 to receive ensartinib or crizotinib. Median PFS was 25.8 months in the ensartinib group vs 12.7 months in the crizotinib group (hazard ratio, 0.56). 

No significant difference was observed in overall survival, but that data are immature. Findings from the eXalt3 trial, published in JAMA Oncology in 2021, highlighted that a 2-year overall survival rate of 78% in both groups. 

“Ensartinib represents a new first-line treatment option for patients with ALK-positive NSCLC,” the study authors wrote at the time.

Adverse reactions occurring in at least 20% of patients included rash, musculoskeletal pain, constipation, cough, pruritus, nausea, edema, pyrexia, and fatigue.

The recommended dose of ensartinib, according to the full prescribing information is 225 mg given orally once daily with or without food until disease progression or unacceptable toxicity. 

Sharon Worcester, MA, is an award-winning medical journalist based in Birmingham, Alabama, writing for Medscape, MDedge and other affiliate sites. She currently covers oncology, but she has also written on a variety of other medical specialties and healthcare topics. She can be reached at[email protected] or on Twitter:@SW_MedReporter.