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The FDA has accepted a new application for gedatolisib (Revtorpyk) plus fulvestrant — with or without palbociclib — for PIK3CA-mutated, HR+, HER2– advanced breast cancer, setting a target action date of June 25, 2027. Data from the VIKTORIA-1 trial showed the gedatolisib triplet nearly doubled progression-free survival compared to alpelisib plus fulvestrant (11.1 vs. 5.6 months). If approved, gedatolisib would be available as second-line therapy regardless of PIK3CA mutation status.
The FDA has accepted a supplemental new drug application (sNDA) for gedatolisib (Revtorpyk) combined with fulvestrant — with or without palbociclib — for adult patients with PIK3CA-mutated, hormone receptor–positive (HR+), HER2-negative locally advanced or metastatic breast cancer that has progressed on at least one line of endocrine therapy. The agency set a PDUFA target action date of June 25, 2027.
The application is backed by data from the phase 3 VIKTORIA-1 trial (Study 2), where the gedatolisib triplet significantly outperformed alpelisib plus fulvestrant. If approved, this would expand gedatolisib's reach beyond its July 2026 approval — which covered patients without a detectable PIK3CA mutation — making it available as second-line therapy regardless of mutation status.
By the Numbers:
Why it matters: PIK3CA mutations are among the most common drivers of HR+/HER2– breast cancer. A therapy that nearly doubles PFS with a more tolerable side effect profile — notably far less hyperglycemia (15% vs. 58%) — could meaningfully shift second-line treatment standards for this large patient population.
