26/08/2026 US FDA Fast Track designation granted for SOT106 in Soft Tissue Sarcoma; First-in-Human Trial Planned in late-2026 US FDA Fast Track designation granted for SYS6090 in MSS/pMMR metastatic colorectal cancer Celcuity submits sNDA to US FDA for approval of gedatolisib combination therapy in PIK3CA-mutant HR+/HER2- advanced breast cancer US FDA Fast Track designation granted for SOT106 in Soft Tissue Sarcoma; First-in-Human Trial Planned in late-2026 (Ref) The US FDA h

03/02/2026 Relay Therapeutics' zovegalisib + fulvestrant received the FDA breakthrough therapy designation for breast cancer The US FDA granted priority review status to Datroway for the treatment of TNBC Relay Therapeutics' zovegalisib + fulvestrant received the FDA breakthrough therapy designation for breast cancer (Ref) The US FDA granted the breakthrough therapy designation to Relay Therapeutics' zovegalisib (PI3Kα inhibitor) + fulvestrant for the treatment of adults with

23/07/2025 Roche's Itovebi regimen received approval in the EU for ER-positive, HER2-negative, advanced breast cancer with a PIK3CA mutation (Ref) The European Commission approved Roche's inavolisib (Itovebi; PIK3CA inhibitor) + palbociclib + fulvestrant for the treatment of adult patients with PIK3CA-mutated, ER+ve, HER2-ve, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment The approval is bas