FDA approves alectinib as adjuvant treatment for ALK-positive non-small cell lung cancer
Regulatory approval: On April 18, 2024, the FDA approved alectinib (Alecensa) for adjuvant treatment after tumor resection in patients with ALK-positive NSCLC, as detected by an FDA-approved test. Approval was based on the global, randomized, open-label ALINA trial, which showed significantly improved investigator-assessed disease-free survival versus platinum-based chemotherapy in stage II–IIIA and overall stage IB–IIIA populations. Recommended dose is 600 mg orally twice daily with food for 2 years or until recurrence/toxicity.
FDA approval (2024-04-18)
The US FDA approved alectinib (Alecensa; Genentech, Inc.) for adjuvant treatment following tumor resection in patients with ALK-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.
Supporting evidence: ALINA (NCT03456076)
Approval was supported by ALINA, a global, randomized, open-label trial in patients with ALK-positive NSCLC who had complete tumor resection. Eligible patients had resectable stage IB (tumors ≥4 cm) to IIIA disease (AJCC 7th edition), with ALK rearrangements identified by a locally performed FDA-approved ALK test or centrally by VENTANA ALK (D5F3) CDx.
A total of 257 patients were randomized 1:1 to alectinib 600 mg orally twice daily or platinum-based chemotherapy after resection.
Efficacy (investigator-assessed DFS)
- Stage II–IIIA subgroup: median DFS not reached with alectinib vs 44.4 months with chemotherapy (HR 0.24, 95% CI 0.13–0.45; p<0.0001).
- Overall stage IB–IIIA: median DFS not reached vs 41.3 months (HR 0.24, 95% CI 0.13–0.43; p<0.0001).
Safety and dosing
Most common (≥20%) adverse reactions: hepatotoxicity, constipation, myalgia, COVID-19, fatigue, rash, cough. Recommended dose: 600 mg twice daily with food for 2 years, or until recurrence or unacceptable toxicity.
Regulatory context
Review was conducted under Project Orbis and used RTOR; the application received priority review and orphan drug designation.