Ensacove FDA Approval History
Last updated by Judith Stewart, BPharm on Dec 28, 2024.
FDA Approved: Yes (First approved December 18, 2024)
Brand name: Ensacove
Generic name: ensartinib
Dosage form: Capsules
Company: Xcovery Holdings, Inc.
Treatment for: Non Small Cell Lung Cancer
Ensacove (ensartinib) is an anaplastic lymphoma kinase (ALK) inhibitor used for the treatment of ALK-positive non-small cell lung cancer.
- Ensacove is indicated for the treatment of adult patients with ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received an ALK-inhibitor.
- NSCLC accounts for 85 percent of all lung cancers in the United States and approximately 5 percent of people with NSCLC are ALK-positive. ALK-positive NSCLC is often found in younger people who have a light or non-smoking history.
- Ensacove works in the treatment of ALK-positive NSCLC by inhibiting ALK and other kinases to suppress cancer cells with ALK point mutations or fusions.
- FDA approval of Ensacove was supported by results of the eXALT3 (NCT02767804) trial comparing ensartinib to crizotinib in patients with ALK-positive NSCLC. Ensartinib demonstrated a statistically significant progression-free survival (PFS) improvement compared to crizotinib, with a median PFS of 25.8 months in the ensartinib arm and 12.7 months in the crizotinib arm. There was no statistically significant difference in overall survival.
- Ensacove capsules are administered orally, once daily, with or without food until disease progression or unacceptable toxicity.
- Warnings and precautions associated with Ensacove include interstitial lung disease (ILD)/pneumonitis, hepatotoxicity, dermatologic adverse reactions, bradycardia, hyperglycemia, visual disturbances, increased creatine phosphokinase, hyperuricemia, and embryo-fetal toxicity.
- Common adverse reactions (incidence ≥20%) include rash, musculoskeletal pain, constipation, pruritus, cough, nausea, edema, vomiting, fatigue, and pyrexia.
Common Grade 3-4 laboratory abnormalities (incidence ≥2%) include increased uric acid, decreased lymphocytes, increased alanine aminotransferase, decreased phosphate, increased gamma glutamyl transferase, increased magnesium, increased amylase, decreased sodium, increased glucose, decreased hemoglobin, increased bilirubin, decreased potassium, and increased creatine phosphokinase.
Development timeline for Ensacove
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.