FDA Approves Alectinib for Early-Stage ALK+ NSCLC

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The FDA has approved alectinib for the adjuvant treatment of patients with ALK-positive non-small cell lung cancer with tumors that are least 4 cm or node positive, as detected by an FDA-approved test.

FDA

FDA

The FDA has approved alectinib (Alecensa) for the adjuvant treatment of patients with ALK-positive non-small cell lung cancer (NSCLC) with tumors that are at least 4 cm or node-positive, as detected by an FDA-approved test.

The approval is based on results from the phase 3 ALINA trial (NCT0346076) assessing alectinib vs chemotherapy for patients with early-stage ALK-positive NSCLC. The risk of death or recurrence was reduced by 76% (HR, 0.24; 95% CI, 0.13-0.43; P <.0001). The disease-free survival (DFS) was also observed in an exploratory analysis and saw an improvement (HR, 0.22; 95% CI, 0.08-0.58).

“The approval of [alectinib] marks a pivotal moment for [patients with] newly diagnosed with early-stage ALK-positive lung cancer, who until now, were not able to receive ALK-specific therapy,” said Ken Culver, director of Research and Clinical Affairs at ALK Positive, Inc. “These patients, who are typically diagnosed at a younger age, often face recurrence and have a higher risk of developing brain metastases than those with other types of NSCLC. Now, with this significant advance, it is more important than ever that all people diagnosed with early-stage lung cancer undergo testing for ALK and other recommended biomarkers to receive the treatment most appropriate for them.”

The study enrolled 257 patients who were randomly assigned to receive either alectinib or chemotherapy. The primary end point was DFS and secondary end points included overall survival, central nervous system DFS, and the amount of patients with adverse effects.

Alectinib was designed to prevent lung cancer occurrence after it had been removed by surgery, or to treat patients where the tumor has metastasized.

References

  1. FDA approves Genentech's Alecensa as first adjuvant treatment for people with ALK-positive early-stage lung cancer. News release. Genentech. April 18, 2024. Accessed April 18, 2024. https://shorturl.at/zSV29
  2. Wu YL, Dziadziuszko R, Ahn JS, et al. Alectinib in resected ALK-positive non-small-cell lung cancer. N Engl J Med. 2024;390(14):1265-1276. doi:10.1056/NEJMoa2310532
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