Roche Holding AG (SWX: ROG; OTCMKTS: RHHBY), a Swiss multinational healthcare company, announced last week that the US Food and Drug Administration (FDA) has granted regulatory approval for Alecensa (alectinib) as an adjuvant treatment for patients with ALK-positive non-small cell lung cancer (NSCLC). This marks the first approval of an ALK inhibitor in the United States for this specific indication. Previously, Alecensa was approved as both first- and second-line treatment for ALK-positive metastatic NSCLC.
The FDA’s decision is based on late-stage clinical trial data that demonstrated the kinase inhibitor’s efficacy in reducing the risk of disease recurrence or death by 76% when compared to chemotherapy. Additionally, the treatment showed a significant improvement in central nervous system (CNS) disease-free survival by 78%. The study did not report any unexpected safety signals, reinforcing the drug’s favorable benefit-risk profile.- Flcube.com
