Olverembatinib: First Approval

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. Sohita Dhillon is a contracted employee of Adis International Ltd/Springer Nature and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

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Abstract

Olverembatinib (HQP1351) is an oral, third-generation BCR-ABL1 tyrosine kinase inhibitor (TKI) developed by Ascentage Pharma for the treatment of chronic myeloid leukaemia (CML), acute myeloid leukaemia, acute lymphoblastic leukaemia (ALL) and solid tumours, including gastrointestinal stromal tumours (GIST). Olverembatinib is an ATP binding-site inhibitor of wild type BCR-ABL1 kinase and a broad spectrum of BCR-ABL1 mutants, including mutant T315I, which confers resistance against all first- and second-generation TKIs. In November 2021, olverembatinib received its first approval in China for the treatment of adult patients with TKI-resistant chronic-phase CML (CML-CP) or accelerated-phase CML (CML-AP) harbouring the T315I mutation, as confirmed by a validated diagnostic test. Clinical studies are underway in the US for CML and precursor cell ALL, and in China for solid tumours, including GIST. This article summarizes the milestones in the development of olverembatinib leading to this first approval for the treatment of CML-CP or CML-AP.

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