Gedatolisib

Oncology Pipeline Update: Prostate Cancer T-Cell Engager Partnership, BTK Inhibitor Filing, and Novel Targeted Therapy Results

Jun 05, 2026

Key oncology developments include a $315 million partnership between Astellas and Vir for the prostate cancer T-cell engager VIR-5500, with updated phase 1 data showing an 82% PSA50 rate. The FDA accepted a filing for Ono Pharmaceuticals' tirabrutinib seeking accelerated approval in primary central nervous system lymphoma. Research findings also identified a new kidney cancer biomarker and showed promising results for the TRK inhibitor repotrectinib and the breast cancer triple therapy gedatolisib plus palbociclib and fulvestrant.

Gedatolisib combinations beat alpelisib regimen in PIK3CA-mutant HR-positive breast cancer

May 05, 2026

Topline phase 3 VIKTORIA-1 results showed gedatolisib combinations improved progression-free survival versus alpelisib plus fulvestrant in PIK3CA-mutant HR-positive/HER2-negative advanced breast cancer. Celcuity plans a supplemental FDA filing based on the data.

January and March 2026 drug pipeline updates span Phase 3, Fast Track and Priority Review

Apr 23, 2026

January and March 2026 drug pipeline updates included Phase 3 results, Fast Track designations and Priority Review decisions across multiple disease areas. Mavacamten, teplizumab-mzwv, anifrolumab, AXS-05, gedatolisib and AFTX-201 were among the programs with notable milestones.

FDA Accepts Celcuity's NDA for Gedatolisib in Advanced Breast Cancer with July 2026 Goal Date

Nov 17, 2025

The FDA has accepted Celcuity's New Drug Application for gedatolisib in HR+/HER2-/PIK3CA wild-type advanced breast cancer, granting Priority Review with a PDUFA goal date of July 17, 2026.