Onco-Summaries: Daily Oncology Updates at a Glance
- Oncofocus Team
- 4 days ago
- 2 min read
26/08/2026
US FDA Fast Track designation granted for SOT106 in Soft Tissue Sarcoma; First-in-Human Trial Planned in late-2026 (Ref)
The US FDA has granted Fast Track Designation (FTD) to SOTIO’s SOT106 (LRRC15-targeted antibody-drug conjugate) for the treatment of soft tissue sarcoma
A first-in-human study of SOT106 is expected to initiate later this year
SOT106 has also received Orphan Drug Designation for osteosarcoma
US FDA Fast Track designation granted for SYS6090 in MSS/pMMR metastatic colorectal cancer (Ref)
CSPC announced that the SYS6090 (JMT108; PD-1 x IL-15 bispecific fusion protein) has received Fast Track designation from the US FDA for treatment of microsatellite-stable (MSS)/pMMR metastatic colorectal cancer (mCRC) after progression on standard therapies
Preclinical findings and ongoing Phase 1 trials in China and the US supported the designation
Celcuity submits sNDA to US FDA for approval of gedatolisib combination therapy in PIK3CA-mutant HR+/HER2- advanced breast cancer (Ref)
Celcuity has submitted a supplemental New Drug Application (sNDA) to the US FDA seeking expanded approval of REVTORPYK™ (gedatolisib), a pan-PI3K/mTOR ("PAM") inhibitor, for patients with HR+/HER2-, PIK3CA-mutant locally advanced or metastatic breast cancer who have progressed after endocrine therapy
The application to the FDA is supported by positive results from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial evaluating triplet gedatolisib + palbociclib + fulvestrant vs doublet gedatolisib + fulvestrant
Study met the primary endpoint by demonstrating statistically significant and clinically meaningful improvement in progression free survival (Ref)
Median PFS: 11.1 months for the triplet vs 11.3 months for the doublet vs 5.6 months for Novartis' alpelisib (PI3Kα-selective inhibitor) + fulvestrant (HR: 0.50 and 0.51; P< 0.0001 and P < 0.0013 respectively)
ORR: 48.9% vs 35.7% vs 26.0%
Median DOR: 15.7 months vs 24.2 months vs 7.5 months
Median OS (Interim Analysis, immature data): NR vs 22.8 months vs 31.1 months
Data represents 45.8% maturity for the final OS analysis in the gedatolisib-triplet and alpelisib + fulvestrant arms
REVTORPYK was FDA-approved in July 2026 for HR+/HER2- breast cancer without PIK3CA mutation (Ref)
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