Olutasidenib: First Approval

<p><strong>Declarations</strong></p> <p><br></p> <p><strong>Funding</strong> The preparation of this review was not supported by any external funding.</p> <p><br></p> <p><strong>Authorship and Conflict of interest </strong>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. Connie Kang is a salaried 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.</p> <p><br></p> <p><strong>Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability </strong>Not applicable.</p> <p><br></p> <p><br></p> <p>Additional information about this Adis Drug Review can be found <a href="https://www.springer.com/gp/adis/products-services/adis-journals-newsletters/adis-drug-reviews" target="_blank">here</a>. </p> <p><br></p> <p>Abstract</p> <p>  </p> <p>Olutasidenib (REZLIDHIA^TM), an isocitrate dehydrogenase-1 (IDH1) inhibitor, is being developed by Rigel Pharmaceuticals for the treatment of relapsed or refractory (R/R) acute myeloid leukaemia (AML). Olutasidenib was recently approved in the USA for the treatment of adults with R/R AML with a susceptible <em>IDH1</em> mutation as detected by a US Food and Drug Administration-approved test. This article summarizes the milestones in the development of olutasidenib leading to this first approval for R/R AML. </p> <p><br></p> <p>  </p> <p>© Springer Nature Switzerland AG 2023</p> <p><br></p> <p><br></p> <p><br></p> <p><br></p>