The US Food and Drug Administration (FDA) has approved the tyrosine kinase inhibitor alectinib (Alecensa) for adjuvant therapy after surgical resection in patients with non-small cell lung cancer (NSCLC, non-small cell lung cancer), who have ALK gene mutations (anaplastic lymphoma kinase), detected by a test authorized by the FDA. This is the first ALK inhibitor approved for early-stage NSCLC.
Approval is based on results the ALINA randomized clinical trial, which included more than 250 patients with resectable NSCLC with tumors positive for ALK gene rearrangements in stage IB to IIIA. Half of them received alectinib, and the other half received chemotherapy with platinum derivatives after tumor resection. Alectinib inhibits ALK proteins and RET.
In patients with stage II to IIIA disease, median disease-free survival was not reached with alectinib, whereas in the control group it was approximately 45 months. Among the entire study population, the median disease-free survival was also not reached, and for the chemotherapy group it was just over 40 months.
The established safety profile was favorable and the most common adverse reactions in patients receiving alectinib were hepatotoxicity, constipation, myalgias, urinary tract infections SARS-CoV-2, fatigue, rashes and cough. Alectinib is administered orally twice daily for 2 years or until disease recurrence or unacceptable toxicity.
The application for alectinib received the distinctions from the FDA Priority Review and Orphan Drug. The agency approved this tyrosine kinase inhibitor a month before the decision was due.
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Tags: FDA approves alectinib adjuvant therapy patients resected nonsmall cell lung cancer positive ALK mutations
