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The FDA on July 14, 2026 approved Revtorpyk (gedatolisib) with fulvestrant, with or without palbociclib, for adults with HR-positive, HER2-negative advanced or metastatic breast cancer without a PIK3CA mutation, after progression on at least one line of endocrine therapy.
Gedatolisib inhibits all four class I PI3K isoforms together with both mTOR complexes, rather than the single alpha isoform targeted by the PI3K inhibitors approved in breast cancer. Celcuity says no other approved drug blocks the pathway at both levels at once.
In VIKTORIA-1, median progression-free survival was 9.3 months on the triplet and 7.4 months on Revtorpyk with fulvestrant, against 2.0 months on fulvestrant alone. Objective responses came in 32% of patients on the triplet and 28% on the doublet, against 1.0%. Survival data were immature, with deaths in 25% of the population. Every patient enrolled had already had endocrine therapy and a CDK4/6 inhibitor.
Stomatitis, severe rash and hyperglycemia all carry warnings, with medicated mouthwash advised before the first dose.
The molecule originated at Wyeth, passed to Pfizer in the 2009 acquisition and stalled in early trials before Celcuity licensed it in 2021 for $10 million upfront. Approval is confined to tumors without a PIK3CA mutation, which is where the trial enrolled and where the result stands in the labeled population.
Sources: FDA prescribing information; Drugs@FDA, NDA 219908; FDA approval notice; Celcuity press release; Pfizer licensing agreement, 2021
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