The U.S. Food and Drug Administration (FDA) announced an update to the label for KRAZATI (adagrasib) on March 25, 2026. This revision clarifies the drug's indication and usage, specifically for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC).
Background
KRAZATI (adagrasib) functions as an inhibitor of the RAS GTPase family. The updated label specifies its indication for non-small cell lung cancer (NSCLC). This includes adult patients with KRAS G12C-mutated NSCLC. The indication further defines the disease stage as locally advanced or metastatic. KRAZATI is to be used as a single agent for the treatment of these adult patients. This precise definition of the patient population and usage context is critical for clinicians.
What this means
The updated label for KRAZATI offers crucial clarity for healthcare professionals. By explicitly detailing the indication for adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), the FDA provides precise guidelines for its use. This specificity ensures that clinicians can accurately identify the appropriate patient population, aligning treatment with the tumor's genetic characteristics. The designation of KRAZATI as a single agent underscores its standalone efficacy in this setting. This clear definition is vital for optimizing patient outcomes, promoting adherence to regulatory standards, and supporting evidence-based practice in the evolving landscape of targeted therapies for lung cancer. It helps to guide clinical decision-making effectively.
Source
The details of this label revision were sourced from the U.S. Food and Drug Administration (FDA). The updated indication and usage information for KRAZATI became effective on March 25, 2026, and is accessible through the DailyMed database hosted by the National Library of Medicine at dailymed.nlm.nih.gov. This public record serves as a primary reference for the drug's approved prescribing information.