FDA

Ensartinib approved for ALK-positive lung cancer

December 20, 2024

Brand name: Ensacove

Generic name: ensartinib

Manufacturer: Xcovery Holdings

Approval date: December 18, 2024

FDA approved Ensacove (ensartinib) for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who haven’t previously received an ALK-inhibitor.

Efficacy

Efficacy was evaluated in eXALT3 (NCT02767804), an open-label, randomized, active-controlled, multicenter trial involving 290 patients with locally advanced or metastatic ALK-positive NSCLC who hadn’t previously received an ALK-targeted therapy. Patients were randomized 1:1 to receive ensartinib or crizotinib.

The main efficacy outcome measure was progression-free survival (PFS) and the key secondary efficacy outcome measure was overall survival (OS). Ensartinib demonstrated a statistically significant PFS improvement compared with crizotinib (hazard ratio [HR], 0.56; 95% CI, 0.40, 0.79; p=0.0007). The median PFS was 25.8 months (95% CI, 21.8, not estimable) in the ensartinib arm vs. 12.7 months (95% CI, 9.2, 16.6) in the crizotinib arm. There was no statistically significant difference in OS (HR, 0.88; 95% CI, 0.63, 1.23; p=0.4570).

Safety

The most common adverse reactions (≥20%) in the trial were rash, musculoskeletal pain, constipation, cough, pruritis, nausea, edema, pyrexia, and fatigue.

Recommended dose

The recommended dose of ensartinib is 225 mg PO once daily, with or without food, until disease progression or unacceptable toxicity.

Sources:

FDA. (2024, December 18). FDA approves ensartinib for ALK-positive locally advanced or metastatic non-small cell lung cancer. [Press release]. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ensartinib-alk-positive-locally-advanced-or-metastatic-non-small-cell-lung-cancer

Xcovery Holdings. (2024, December 18). FDA Approval of Ensartinib for ALK-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC). [Press release]. https://www.businesswire.com/news/home/20241218355621/en/FDA-Approval-of-Ensartinib-for-ALK-Positive-Locally-Advanced-or-Metastatic-Non-Small-Cell-Lung-Cancer-NSCLC

Xcovery Holdings: Ensacove (ensartinib). [Package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218171s000lbl.pdf