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oai:figshare.com:article/33769543 2026-09-29T23:43:20Z category_7 portal_333 item_type_11 month_year_09_2026

Gedatolisib: First Approval Hannah A. Blair (13864794) Medicine Gedatolisib HR+/HER2− advanced breast cancer review Adis Insight Report <p dir="ltr"><b>Declarations</b></p><p dir="ltr"><b>Authorship and Conflict of interest</b> 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 A. 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.</p><p dir="ltr"><b>Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability </b>Not applicable.</p><p dir="ltr">Additional information about this Adis Drug Review can be found <a href="http://www.springer.com/gp/adis/products-services/adis-journals-newsletters/adis-drug-reviews" target="_blank"><b>here</b></a>.</p><p dir="ltr"><b>Abstract</b></p><p dir="ltr">Gedatolisib (REVTORPYK^®) is a kinase inhibitor of class I phosphatidylinositol 3-kinase (PI3K) isoforms and mechanistic target of rapamycin (mTOR) complexes. It is being developed by Celcuity, under a license from Pfizer, for the treatment of various cancers. <i>PIK3CA</i>, which encodes the catalytic subunit of PI3K, is frequently mutated in a range of cancers, including breast cancer. Gedatolisib received its first approval in the USA on 14 July 2026 for use in combination with fulvestrant, with or without palbociclib, for the treatment of adult patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2–) locally advanced or metastatic breast cancer without a <i>PIK3CA</i> mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. This article summarizes the milestones in the development of gedatolisib leading to this first approval for HR+/HER2– breast cancer.</p><p dir="ltr">© Springer Nature Switzerland AG 2026</p> 2026-09-29T23:43:20Z Text Online resource 10.6084/m9.figshare.33769543.v1 https://figshare.com/articles/online_resource/Gedatolisib_First_Approval/33769543 CC BY-NC 4.0