Adagrasib: First Approval

Sohita Dhillon1

  • 1Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand. dru@adis.com.

Drugs
|February 10, 2023
PubMed

Insights

Adagrasib is a new KRAS G12C inhibitor approved for non-small cell lung cancer (NSCLC). This targeted therapy offers a new treatment option for patients with this specific genetic mutation.

Area of Science:

  • Oncology
  • Molecular Biology
  • Drug Development

Background:

  • KRAS G12C mutations are key drivers in various solid tumors, including non-small cell lung cancer (NSCLC) and colorectal cancer (CRC).
  • Targeted therapies inhibiting KRAS G12C offer a promising approach to cancer treatment.
  • Adagrasib is a potent, irreversible small molecule inhibitor specifically designed for the KRAS G12C mutant isoform.

Purpose of the Study:

  • To summarize the development milestones of adagrasib.
  • To highlight the first FDA approval of adagrasib for KRAS G12C-mutated NSCLC.
  • To provide an overview of adagrasib's mechanism of action and ongoing clinical development.

Main Methods:

  • Review of preclinical and clinical development data for adagrasib.
  • Analysis of regulatory submission and approval process in the USA.
  • Summary of adagrasib's mechanism of action, including covalent binding to KRAS G12C.

Main Results:

  • Adagrasib received accelerated FDA approval in December 2022 for adults with KRAS G12C-mutated locally advanced or metastatic NSCLC.
  • Approval was based on objective response rate and duration of response.
  • Adagrasib is under regulatory review in the EU for NSCLC and in development for CRC in the US.

Conclusions:

  • Adagrasib represents a significant advancement in targeted therapy for KRAS G12C-mutated NSCLC.
  • The drug's development highlights the success of precision medicine in oncology.
  • Continued clinical trials are essential to confirm clinical benefit and expand indications.

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