Mirati’s Krazati Gets Accelerated Approval for NSCLC

Title: Mirati’s Krazati Receives Accelerated Approval for NSCLC: A Promising Breakthrough in Lung Cancer Treatment


In a significant development in the field of lung cancer treatment, Mirati Therapeutics has received accelerated approval for its groundbreaking drug, Krazati, for the treatment of non-small cell lung cancer (NSCLC). This blog post will provide an overview of this milestone achievement, emphasizing the key points surrounding Krazati’s accelerated approval and its potential impact on NSCLC patients.

Key Points:

  1. The Significance of Krazati’s Accelerated Approval:
    The accelerated approval granted to Mirati’s Krazati represents a notable advancement in the treatment options available for NSCLC patients. NSCLC is the most common form of lung cancer, accounting for approximately 80-85% of cases. The approval of Krazati provides a promising new treatment avenue for patients who have been limited in their options, particularly those with specific genetic mutations.
  2. Targeting KRAS G12C Mutation:
    Krazati is a targeted therapy that specifically focuses on the KRAS G12C mutation, which is present in approximately 13% of NSCLC patients. This genetic alteration has long been considered challenging to target, making Krazati’s approval a significant breakthrough. By directly inhibiting the mutated KRAS protein, Krazati aims to disrupt cancer cell growth, potentially leading to improved outcomes for patients with this specific mutation.
  3. Accelerated Approval Process:
    The accelerated approval granted to Krazati by regulatory authorities recognizes the urgent need for innovative treatments in oncology. This expedited pathway allows for the approval of drugs based on preliminary clinical evidence, providing patients with earlier access to potentially life-saving therapies. Continued monitoring and study of Krazati’s efficacy and safety will be required to confirm the drug’s long-term benefits.
  4. Positive Clinical Trial Results:
    The accelerated approval of Krazati is supported by promising results from its clinical trials. In a Phase 1/2 study, Krazati demonstrated encouraging efficacy in patients with the KRAS G12C mutation, showing tumor shrinkage and prolonged progression-free survival. These results provide initial evidence of Krazati’s potential as an effective treatment option for NSCLC patients with this specific genetic alteration.
  5. Potential Implications for NSCLC Treatment:
    The approval of Krazati marks a significant step toward personalized medicine in NSCLC treatment. By targeting a specific genetic mutation, Krazati exemplifies the growing trend of precision oncology, where therapies are tailored to a patient’s unique genetic profile. The success of Krazati opens up possibilities for further research and development of targeted therapies for other genetic mutations, providing hope for improved outcomes in the future.
  6. Ongoing Research and Future Outlook:
    While the accelerated approval of Krazati is undoubtedly exciting news for NSCLC patients, ongoing research and clinical trials are essential for further validating the drug’s long-term efficacy and safety. Continued investigations will help identify potential combination therapies, explore the drug’s role across different stages of NSCLC, and broaden its reach to other cancer types with the KRAS G12C mutation.


The accelerated approval of Mirati’s Krazati for the treatment of NSCLC with the KRAS G12C mutation represents a significant stride forward in lung cancer therapeutics. With its ability to target this specific genetic alteration, Krazati offers hope for NSCLC patients who previously had limited treatment options. While further research and observations are necessary, the approval of Krazati highlights the potential of precision medicine to revolutionize cancer treatment and improve outcomes for patients in the future.