FDA: Priority Review for Alectinib for ALK-positive NSCLC

metastatic lung cancer_G_160936361
metastatic lung cancer_G_160936361
Priority review for alectinib was granted based on evidence from the phase 3 ALEX and J-ALEX clinical trials.

Editor’s note: This article was updated to amend an error in a stated confidence interval.

The US Food and Drug Administration (FDA) has granted priority review to alectinib for the treatment of patients with ALK-positive, locally advanced or metastatic non–small cell lung cancer (NSCLC).1

Alectinib was previously granted accelerated approval for the treatment of ALK-positive metastatic NSCLC resistant to crizotinib.

The FDA granted priority review based on evidence from the phase 3 ALEX (ClinicalTrials.gov Identifier: NCT02075840) and J-ALEX trials, the latter of which was conducted in Japan.

For the ALEX trial, researchers randomly assigned 303 treatment-naive patients with ALK-positive NSCLC to receive alectinib 600 mg twice daily or crizotinib 250 mg twice daily.

Alectinib decreased the risk of disease-progression and death by 53% vs crizotinib (hazard ratio [HR], 0.47; 95% CI, 0.34-0.65; P <.0001).

Patients receiving alectinib did not reach investigator-reported median progression-free survival (PFS) (95% CI, 17.7-not reached) vs 11.1 months (95% CI, 9.1-13.1) in the crizotinib arm. The independent review committee–reported median PFS was 25.7 months (95% CI, 19.9-not reached) for the alectinib group vs 10.4 months (95% CI: 7.7-14.6) for the crizotinib group (HR, 0.50; 95% CI, .036-0.70; P < .0001).

The risk of progression into the central nervous system was reduced by 84% (HR, 0.16; 95% CI, 0.10-0.28; P < .0001) with alectinib compared with crizotinib.

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The J-ALEX trial results also showed favorable efficacy.2

Both the ALEX and J-ALEX trials reported a lower frequency of grade 3 to 5 adverse events in the alectinib group vs the crizotinib group.

A decision for approval will be made by November 30, 2017.


  1. FDA grants Genentech’s alecensa priority review for initial treatment of people with ALK-positive lung cancer [news release]. South San Francisco, CA: BusinessWire; August 3, 2017. http://www.businesswire.com/ news/home/20170802006635/en/FDA-Grants-Genentech%E2%80%99s-Alecensa-Priority-Review-Initial. Accessed August 3, 2017.
  2. Hida T, Nokihara H, Kim YH, et al. Alectinib versus crizotinib in patients with ALK-positive non-small-cell lung cancer (J-ALEX): an open-label, randomized phase 3 trial. Lancet. 2017;390(10089):29-39. doi:10.1016/S0140-6736(17)30565-2

This article originally appeared on Cancer Therapy Advisor