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Establishment and Characterization of Three Afatinib-resistant Lung Adenocarcinoma PC-9 Cell Lines Developed with Increasing Doses of Afatinib
09:38

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Afatinib: first global approval.

Rosselle T Dungo1, Gillian M Keating

  • 1Adis R & D Insight, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore, 0754, Auckland, New Zealand, dru@adis.com.

Drugs
|August 29, 2013
PubMed
Summary
This summary is machine-generated.

Afatinib, an irreversible ErbB family inhibitor, is approved for metastatic non-small-cell lung cancer (NSCLC) with specific EGFR mutations. This oral treatment offers a new option for patients with advanced NSCLC.

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Area of Science:

  • Oncology
  • Pharmacology
  • Molecular Biology

Background:

  • Afatinib is an irreversible ErbB family tyrosine kinase inhibitor.
  • It targets epidermal growth factor receptor (EGFR), human epidermal growth factor receptor (HER) 2, and HER4.
  • Afatinib downregulates ErbB signaling by inhibiting tyrosine kinase autophosphorylation and HER3 transphosphorylation.

Purpose of the Study:

  • To summarize the development milestones of afatinib.
  • To highlight the first approval of afatinib for metastatic non-small-cell lung cancer (NSCLC).

Main Methods:

  • Review of afatinib's mechanism of action.
  • Summary of regulatory approvals and reviews in various regions.

Main Results:

  • Afatinib (Gilotrif™) is approved in the US for first-line treatment of metastatic NSCLC with EGFR exon 19 deletions or exon 21 (L858R) mutations.
  • Approved in Taiwan for first-line EGFR mutation-positive NSCLC.
  • Recommended for approval in Europe for EGFR tyrosine kinase inhibitor-naïve patients with advanced or metastatic NSCLC and activating EGFR mutations.

Conclusions:

  • Afatinib represents a significant advancement in the treatment of EGFR mutation-positive NSCLC.
  • The drug's development has led to key regulatory approvals, offering a new therapeutic option for patients with metastatic NSCLC.