FDA approves ensartinib for metastatic non-small cell lung cancer
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The FDA approved ensartinib for the treatment of certain patients with ALK-positive locally advanced or metastatic non-small cell lung cancer.
The indication applies to use of the agent for adults not previously prescribed an ALK inhibitor.
The FDA approved ensartinib (Ensacove, Xcovery Holdings Inc.) based on data from the 1:1 randomized eXALT3 trial, which included 290 patients with locally advanced or metastatic ALK-positive non-small cell lung cancer who had not previously received an ALK-targeted therapy.
Patients received ensartinib or crizotinib (Xalkori, Pfizer).
PFS served as the main efficacy outcome measure, with OS as a key secondary efficacy outcome.
Patients who received ensartinib experienced greater median PFS than those receiving crizotinib (25.8 months vs. 12.7 months; HR = 0.56; 95% CI, 0.4-0.79).
Researchers observed no significant difference in OS (HR = 0.88; 95% CI, 0.63-1.23).
Adverse reactions that occurred in at least 20% of patients included rash, musculoskeletal pain, constipation, cough, pruritus, nausea, edema, pyrexia and fatigue.
The recommended dose for ensartinib is 225 mg/day orally with or without food until disease progression or unacceptable toxicity.
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