Celcuity submits FDA sNDA for REVTORPYK in PIK3CA-mutant advanced breast cancer - CELC News | RalliesCelcuity submits FDA sNDA for REVTORPYK in PIK3CA-mutant advanced breast cancer
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CELC• FDA supplemental filing for REVTORPYK
- Celcuity filed a supplemental NDA with the FDA for REVTORPYK (gedatolisib) in HR+/HER2- advanced breast cancer with PIK3CA mutations.
- Submission targets patients whose disease progressed on or after at least one line of endocrine therapy.
- VIKTORIA-1 data showed PFS of 11.1 months with the triplet vs 5.6 months for alpelisib-fulvestrant; HR 0.5.
- REVTORPYK won FDA clearance on July 14, 2026 for the same setting in PIK3CA wild-type disease.
