Alectinib Granted FDA Approval as First-line Therapy for ALK-positive NSCLC
Approval was based on results from ALEX, in which patients with ALK-positive NSCLC not previously treated with systemic therapy were randomly assigned to receive alectinib or crizotinib.
The US Food and Drug Administration (FDA) granted approval to alectinib as a first-line therapy for patients with ALK-positive metastatic non–small cell lung cancer (NSCLC), according to a press release.1
The FDA based its approval on results from the open-label phase 3 ALEX trial (ClinicalTrials.gov Identifier: NCT02075840), for which researchers randomly assigned 303 patients with ALK-positive NSCLC not previously treated with systemic therapy to receive alectinib or crizotinib.
Patients treated with alectinib had a significantly reduced risk of disease progression or death of 47% (hazard ratio [HR], 0.53; 95% CI, 0.38-0.73; P < .0001) compared with patients treated with crizotinib.
The median progression-free survival (PFS) was 25.7 months (95% CI, 19.9-not evaluable) vs 10.4 months (95% CI, 7.7-14.6) for patients in the alectinib vs crizotinib arm, respectively.
Patients treated with alectinib also had a lower risk of brain or central nervous system metastases compared with those treated with crizotinib (85%; HR, 0.16; 95% CI, 0.10-0.28; P < .0001).
Updated safety reports for alectinib remained consistent with those previously reported from prior studies. The most frequently reported grade 3 and 4 adverse reactions included kidney dysfunction, hyponatremia, impaired liver function, and anemia.
1. FDA approves Roche's Alecensa (alectinib) as first-line treatment for people with specific type of lung cancer [news release]. Basel, Switzerland: Roche; November 7, 2017. https://www.roche.com/media/store/releases/med-cor-2017-11-07.htm?utm_source=360Works%20CloudMail&utm_medium=email&utm_campaign=12739. Accessed November 7, 2017.