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These highlights do not include all the information needed to use REVTORPYK safely and effectively. See full prescribing information for REVTORPYK.REVTORPYK (gedatolisib) for Injection, for intravenous infusionInitial U.S. Approval: 2026
Medication labelWhy this: Advisory · dailymed-prescription
REVTORPYK is indicated in combination with fulvestrant, with or without palbociclib, for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting [see Dosage and Administration (2.1) and Clinical Studies (14)].
- generic_name
- gedatolisib
- product_names
- gedatolisib
- ndc
- 84577-751, 84577-751-01
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en