HR+/HER2-/PIK3CA Wild-Type Advanced Breast Cancer (ABC)
CELCCelcuityCatalyst overview
Research summary
This catalyst tracks a Approved update for Gedatolisib + palbociclib + fulvestrant (gedatolisib triplet) in HR+/HER2-/PIK3CA Wild-Type Advanced Breast Cancer (ABC). The expected timing is based on the latest available company guidance and may change.
05/14/26:- PDUFA remains July 17, 2026; ASCO data June 2 and sNDA planned Q3 2026. 06/02/26:- Priority Review confirmed; PDUFA remains July 17, 2026. VIKTORIA-1 MT data support planned sNDA; timing TBA. 07/14/26:- FDA approved Revtorpyk for HR+/HER2- PIK3CA WT mBC. Launch planned late Q3 2026. 08/13/26:- Commercial launch activities commenced. Revtorpyk shipments are expected late Q3 2026.
Verification
Confirm timing and program details against the company announcement or filing.