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Befotertinib: First Approval.

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Befotertinib (Surmana®) is a new EGFR TKI approved in China for advanced non-small cell lung cancer. It treats patients progressing after prior EGFR TKI therapy with the T790M mutation.

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Area of Science:

  • Oncology
  • Pharmacology

Background:

  • Befotertinib (Surmana®) is a third-generation, oral, selective epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI).
  • It is developed by Betta Pharmaceuticals and InventisBio for non-small cell lung cancer (NSCLC).

Purpose of the Study:

  • To summarize the development milestones of befotertinib.
  • To highlight its first approval for specific non-small cell lung cancer patients.

Main Methods:

  • Review of clinical development and regulatory milestones.
  • Focus on the approval for second-line treatment of EGFR T790M-mutated NSCLC.

Main Results:

  • Befotertinib received approval in China in May 2023.
  • The approval is for second-line treatment of locally advanced or metastatic NSCLC with EGFR T790M mutation after prior EGFR TKI therapy.

Conclusions:

  • Befotertinib represents a significant advancement for NSCLC treatment in China.
  • Ongoing studies are exploring its use in first-line and adjuvant settings.