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FDA grants priority review to alectinib for ALK-positive lung cancer
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The FDA granted priority review to alectinib for the treatment of patients with locally advanced or metastatic anaplastic lymphoma kinase-positive non–small cell lung cancer who progressed on or are intolerant to crizotinib.
“There is a need for new treatment options in this patient population, especially because the disease often spreads to the brain at progression,” Sandra Horning, MD, chief medical officer and head of global product development at Genentech, said in a press release.
The FDA based its decision on two phase 2 studies presented at this year’s ASCO Annual Meeting. Both studies demonstrated the antitumor activity of alectinib (Genentech) — an oral investigational ALK inhibitor — in patients with ALK-positive NSCLC who progressed on crizotinib (Xalkori, Pfizer).
The single-arm, open-label, multicenter NP28761 trial included 87 patients.
An independent review committee calculated an objective response rate of 47.8% (95% CI, 35.6-60.2). The committee determined alectinib induced responses in 68.8% (95% CI, 41.3-89) of patients whose disease had spread to the brain or other parts of central nervous system by study entry.
Preliminary data showed a 7.5-month median duration of response and a median PFS of 6.3 months (95% CI, 5.5-not estimable). The most frequent grade 3 or higher adverse events included increased muscle enzymes (8%), increased alanine aminotransferase (6%), increased aspartate aminotransferase (5%) and shortness of breath (3%).
The single-arm, open-label, multicenter NP28673 trial included 138 patients.
An independent review committee calculated an overall objective response rate of 50% (95% CI, 40.8-59.1). The committee determined alectinib induced responses in 57.1% (95% CI, 39.4-73.7) of patients whose disease had spread to the brain or other parts of the CNS by study entry.
Preliminary data showed an 11.2-month median duration of response (95% CI, 9.6-not estimable). Researchers reported a median PFS of 8.9 months (95% CI, 5.6-11.3).
The most frequent grade 3 or higher adverse event was shortness of breath (4%).
The FDA granted breakthrough therapy designation to alectinib in 2013 for treatment of individuals with ALK-positive NSCLC who progressed during treatment with crizotinib. The agency is expected to decide whether to approve alectinib for this indication by March 4, 2016.
The ongoing randomized, phase 3 ALEX trial is designed to compare alectinib with crizotinib for first-line treatment of patients with advanced ALK-positive NSCLC.