Kinase Inhibitor Approved for Resectable Lung Cancer
The FDA has approved the ALK inhibitor alectinib for surgically resectable NSCLC.
The U.S. Food and Drug Administration (FDA) has approved alectinib (Alecensa) for use after the surgical removal of a non-small cell lung cancer (NSCLC) tumor that overexpresses or harbors a mutant form of the anaplastic lymphoma kinase (ALK).
Alectinib is an inhibitor of ALK, a protein that, when mutated or involved in a gene rearrangement, drives tumor growth in several cancer types, including NSCLC. It had been previously approved for use in patients with metastatic NSCLC. The current approval expands the use of alectinib to include patients with NSCLC that can be surgically removed.
This approval is based on results from the global, randomized, open-label, phase III ALINA trial in which 257 patients with NSCLC were randomly assigned (1:1) to receive alectinib or platinum-based chemotherapy after surgical resection. All patients had tumors that were stage 1B to 3A, had ALK overexpression or mutations, and were safe to surgically remove.
In the overall trial population, the median disease-free survival was not reached in the alectinib arm and was 41.3 months in the chemotherapy arm. Among patients with stage 2 to 3A tumors, the median disease-free survival was not reached in the alectinib arm and was 44.4 months in the chemotherapy arm.
The recommended dose of alectinib is 600 mg twice a day with food until disease recurrence or unacceptable toxicity, for a maximum of two years.
NSCLC is the most common type of lung cancer, accounting for over 80% of all lung cancer cases. According to federal statistics, it was estimated that 234,580 individuals would be diagnosed with lung cancer and 125,070 patients would die of the disease in the United States in 2024.
The FDA rendered its decision on April 18, 2024.
