medwireNews: Alectinib has been granted regular approval by the US Food and Drug Administration (FDA) for the first-line treatment of patients with metastatic non-small-cell lung cancer (NSCLC) that has tested positive for the anaplastic lymphoma kinase (ALK) rearrangement.
The ALK inhibitor had previously been granted accelerated approval for patients with ALK-positive metastatic NSCLC that had progressed during treatment with crizotinib, or were intolerant of this first-generation ALK inhibitor.
Alectinib may now be given to patients with previously untreated metastatic disease with an ALK mutation confirmed by an FDA-approved test, with a recommended dosage of 600 mg twice daily.
The latest approval follows results from the ALEX trial that were presented simultaneously at the ASCO 2017 meeting and in The New England Journal of Medicine. Further results from the ALEX trial were later reported at the ESMO 2017 Congress.
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