Onco-Summaries: Daily Oncology Updates at a Glance

08/05/2026

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• FDA grants RMAT designation to RZ-001, Algenomics’ RNA-based gene therapy for hepatocellular carcinoma, accelerating U.S. development and global partnership opportunities

  
  

• Sacituzumab tirumotecan + pembrolizumab gains NMPA priority review after landmark Phase III success in first‑line PD‑L1+ NSCLC

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FDA grants RMAT designation to RZ-001, Algenomics’ RNA-based gene therapy for hepatocellular carcinoma, accelerating U.S. development and global partnership opportunities (Ref)

Algenomics’ RNA-based gene therapy RZ-001 for primary hepatocellular carcinoma (HCC) has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. FDA on May 7, 2026

Interim Phase 1b/2a trial results presented at AACR 2026 showed meaningful early signals, which contributed to the FDA’s recognition of its innovation and potential

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Sacituzumab tirumotecan + pembrolizumab gains NMPA priority review after landmark Phase III success in first‑line PD‑L1+ NSCLC (Ref)

Kelun-Biotech’s sNDA for sacituzumab tirumotecan (sac‑TMT, SKB264/MK‑2870) combined with pembrolizumab (KEYTRUDA®) as first‑line treatment for PD‑L1‑positive NSCLC has been accepted for review by China’s NMPA

The application is supported by positive Phase III results from the OptiTROP‑Lung05 trial, which met its primary endpoint of progression‑free survival (PFS) and showed a favorable trend in overall survival (OS)

Results will be presented at the 2026 ASCO Annual Meeting (Abstract #8506)

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