Posted by A new chapter in targeted cancer therapy
On July 14, 2026, the U.S. FDA approved REVTORPYK™ (gedatolisib), developed by Celcuity, for adults with hormone receptor-positive (HR+), HER2-negative locally advanced or metastatic breast cancer without a detectable PIK3CA mutation, following progression after at least one line of endocrine therapy in the metastatic setting.
REVTORPYK for injection is a preservative-free, lyophilized powder. Each vial delivers 180 mg of gedatolisib. The lyophilized powder also contains 720 mg of hydroxypropyl β cyclodextrin and 48.6 mg of lactic acid.
What makes this approval particularly interesting from a drug-development perspective is the breadth of gedatolisib’s molecular target profile. Rather than inhibiting a single component of the PI3K/AKT/mTOR signaling network, gedatolisib simultaneously targets all four class I PI3K isoforms—PI3Kα, PI3Kβ, PI3Kδ and PI3Kγ—as well as the two major mTOR complexes, mTORC1 and mTORC2. The result is a more comprehensive blockade of the PI3K/AKT/mTOR pathway, one of the most important signaling networks involved in cancer-cell growth and survival.
From molecular concept to clinical benefit
The FDA approval was supported by the Phase 3 VIKTORIA-1 trial, which evaluated gedatolisib in combination with fulvestrant, with or without palbociclib. In the PIK3CA wild-type population, the combination of gedatolisib, fulvestrant and palbociclib reduced the risk of disease progression or death by 76%, while gedatolisib plus fulvestrant reduced the risk by 67%, compared with fulvestrant alone.
These results illustrate an important principle in modern oncology: the biological complexity of a disease pathway may require more than a single molecular intervention. By simultaneously addressing multiple nodes of the PI3K/mTOR pathway, gedatolisib represents a distinctly different pharmacological strategy from therapies directed primarily at PI3Kα, AKT or mTORC1.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219908Orig1s000lbl.pdf
Image credits: http://www.celcuity.com