Mirati’s Krazati Gets Accelerated Approval for NSCLC

Title: Mirati’s Krazati Receives Accelerated Approval for NSCLC: A New Hope for Lung Cancer Patients


Lung cancer remains one of the leading causes of cancer-related deaths worldwide, necessitating the development of innovative therapies. In a significant breakthrough, Mirati Therapeutics has achieved accelerated approval from regulatory authorities for their novel drug, Krazati, in the treatment of non-small cell lung cancer (NSCLC). This blog post will focus on the key points surrounding the accelerated approval of Krazati, highlighting its potential to provide new hope for NSCLC patients.

Key Points:

  1. Non-Small Cell Lung Cancer (NSCLC):
    • NSCLC is the most common type of lung cancer, accounting for around 85% of all cases.
    • It is a complex disease with various subtypes and genetic alterations, necessitating personalized treatment approaches.
  2. Mirati’s Krazati:
    • Krazati is a novel targeted therapy developed by Mirati Therapeutics.
    • It specifically targets a specific genetic alteration known as KRAS G12C, which is present in approximately 13% of NSCLC patients.
  3. Accelerated Approval Pathway:
    • The accelerated approval pathway allows for the expedited review and approval of promising therapies for serious conditions where there are limited treatment options.
    • It is based on early clinical data suggesting substantial potential benefits, which may be confirmed through ongoing studies.
  4. Clinical Trial Results:
    • The accelerated approval of Krazati was based on encouraging results from early-stage clinical trials.
    • These trials demonstrated meaningful response rates and prolonged survival outcomes in NSCLC patients with the KRAS G12C mutation.
  5. Potential Impact:
    • The approval of Krazati represents a significant advancement in the treatment of NSCLC, providing a targeted therapy option for patients with the KRAS G12C mutation.
    • It offers new hope for a subgroup of NSCLC patients who previously had limited treatment options.
  6. Combination Therapy Potential:
    • Krazati’s accelerated approval opens the doors for further exploration of combination therapy approaches.
    • Researchers and clinicians may explore combining Krazati with other targeted therapies, immunotherapies, or chemotherapy to enhance treatment efficacy and overcome resistance mechanisms.
  7. Ongoing Studies and Future Directions:
    • While accelerated approval allows for earlier access to the therapy, further studies are ongoing to confirm its long-term efficacy and safety.
    • Continuous monitoring and assessment of Krazati’s performance in real-world settings will provide valuable insights for future treatment strategies.


The accelerated approval of Mirati’s Krazati for NSCLC marks a significant milestone in the field of lung cancer treatment. Targeting the KRAS G12C mutation, Krazati offers a new ray of hope for NSCLC patients who previously faced limited treatment options. While further studies are underway to validate its long-term efficacy and safety, the accelerated approval pathway provides earlier access to this promising therapy. With ongoing research and potential combination therapy approaches, Krazati has the potential to transform the landscape of NSCLC treatment and improve the lives of patients worldwide. The approval of Krazati represents yet another step towards the goal of personalized medicine, where targeted therapies tailored to specific genetic alterations offer new avenues for successful cancer treatment.