Befotertinib plain language summary slide with DOI 20 Sep.pdf (243.56 kB)

Befotertinib: First Approval

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posted on 2023-09-19, 23:27 authored by Hannah A. Blair

Declarations

Funding The preparation of this review was not supported by any external funding.

Authorship and Conflict of interest During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Hannah Blair is a salaried employee of Adis International Ltd/Springer Nature and declares no relevant conflicts of interest. All authors contributed to this article and are responsible for its content.

Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability Not applicable.

Additional information about this Adis Drug Review can be found here.

Abstract

Befotertinib (Surmana®) is an orally administered, highly selective, third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) being developed by Betta Pharmaceuticals and InventisBio for the treatment of non-small cell lung cancer (NSCLC). In May 2023, befotertinib was approved in China for the second-line treatment of patients with locally advanced or metastatic NSCLC who have received EGFR TKI therapy and have disease progression with positive EGFR T790M mutation. Befotertinib is under regulatory review for the first-line treatment of NSCLC in China. Clinical studies assessing befotertinib as an adjuvant therapy after surgery for early EGFR-mutant NSCLC (phase III) and in combination with icotinib for advanced or metastatic EGFR-mutant NSCLC (phase II) are currently underway in China. This article summarizes the milestones in the development of befotertinib leading to this first approval for the second-line treatment of EGFR T790M-mutated locally advanced or metastatic NSCLC.