The U.S. Food and Drug Administration (FDA) has approved Alecensa (alectinib) for the treatment of patients with ALK-positive non-small cell lung cancer (NSCLC) following surgical removal of the tumor.
This approval stems from the Phase III ALINA study, which demonstrated a significant reduction in the risk of disease recurrence or death by 76% in patients treated with Alecensa compared to standard chemotherapy. The study also showed an improvement in central nervous system (CNS)-disease-free survival.
The approval of Alecensa for adjuvant therapy marks a significant advancement for patients with ALK-positive early-stage lung cancer. “With an unprecedented 76% reduction in the risk of disease recurrence or death versus chemotherapy, Alecensa significantly improves upon the standard of care for people with early-stage ALK-positive lung cancer,” said Dr. Levi Garraway, Chief Medical Officer at Genentech.
Lung cancer is a common and life-threatening disease, with non-small cell lung cancer accounting for the majority of cases. Early-stage NSCLC is often treated with surgery to remove the tumor, but many patients experience recurrence despite adjuvant chemotherapy.
The approval of Alecensa highlights the importance of testing for ALK and other biomarkers in patients with early-stage NSCLC to guide treatment decisions. This allows for targeted therapies like Alecensa to be administered, offering the best chance of cure and improving patient outcomes.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
