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FDA approves ensartinib for ALK-positive locally advanced or metastatic non-small cell lung cancer

What's New: Drugs RSS Feed · By FDA ·

The Brief

  • On December 18, 2024, the FDA approved ensartinib (brand name Ensacove, from Xcovery Holdings, Inc.).
  • The approval covers adults with locally advanced or metastatic ALK-positive non-small cell lung cancer who have not previously received an ALK inhibitor.
  • The source is an FDA approval notice, republished in a drugs RSS feed dated 2026-11-07.

Why it matters

It adds an oral targeted treatment option for a defined subgroup of lung cancer patients, and it is relevant to oncology researchers and clinicians tracking ALK-inhibitor therapies.

Who’s affected

  • Adults with ALK-positive locally advanced or metastatic NSCLC who have not previously received an ALK inhibitor

On December 18, 2024, the Food and Drug Administration approved ensartinib (Ensacove, Xcovery Holdings, Inc.) for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received an…

Timeline

  1. FDA approves ensartinib (Ensacove) for ALK-positive NSCLC

  2. What's New: Drugs RSS Feed

    FDA approves ensartinib for ALK-positive locally advanced or metastatic non-small cell lung cancer

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