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Related Experiment Video

Updated: Mar 18, 2026

Scaled-Up Preparation of an Intermediate of Upatinib, ACT051-3
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Olmutinib: First Global Approval.

Esther S Kim1

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

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|July 1, 2016
PubMed
Summary
This summary is machine-generated.

Olmutinib, a third-generation EGFR TKI, offers a new treatment for non-small cell lung cancer (NSCLC) by targeting specific mutations. It received its first global approval in South Korea for EGFR T790M mutation-positive NSCLC.

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A Method for Screening and Validation of Resistant Mutations Against Kinase Inhibitors
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Area of Science:

  • Oncology
  • Pharmacology

Background:

  • Non-small cell lung cancer (NSCLC) often develops resistance to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR TKIs).
  • The T790M mutation is a primary mechanism for acquired resistance to first and second-generation EGFR TKIs.
  • Third-generation EGFR TKIs, like olmutinib, are designed to overcome this resistance.

Purpose of the Study:

  • To summarize the development milestones of olmutinib.
  • To highlight the drug's journey leading to its first global approval.

Main Methods:

  • Olmutinib is an oral, third-generation EGFR TKI.
  • It covalently binds to EGFR, irreversibly inhibiting activating mutations and the T790M resistance mutation.
  • It spares wild-type EGFR, potentially reducing side effects.

Main Results:

  • Olmutinib received US FDA breakthrough therapy designation in December 2015 for NSCLC.
  • In May 2016, olmutinib gained its first global approval in South Korea.
  • Approval is for locally advanced or metastatic EGFR T790M mutation-positive NSCLC.

Conclusions:

  • Olmutinib represents a significant advancement in NSCLC treatment, particularly for patients with T790M mutations.
  • Its development and approval mark a milestone in targeted cancer therapy.
  • The drug's mechanism offers a more selective approach to inhibiting resistant EGFR mutations.