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Nov 6, 2026Regulatory decision

FDA approved alectinib for adjuvant ALK-positive NSCLC on April 18, 2024

The approval covers use after tumor resection in patients with ALK-positive non-small cell lung cancer identified by an FDA-approved test.

On April 18, 2024, the Food and Drug Administration approved alectinib (Alecensa, Genentech, Inc.) for adjuvant treatment following tumor resection in patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.1

The approval record does not provide further detail on dosing, trial results, or the specific companion diagnostic used to identify ALK-positive status. Readers seeking those specifics should consult the full prescribing information and the FDA's approval documentation directly, as the source provided here contains only the approval announcement itself.

Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.