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Onco-Summaries: Daily Oncology Updates at a Glance
09/06/2026 Imugene’s Azer-cel secures FDA Fast Track for CLL/SLL and MZL FDA grants RedHill’s opaganib Rare Pediatric Disease designation for neuroblastoma Serplulimab secures world‑first approval as a chemo‑sparing perioperative immunotherapy for gastric cancer FDA grants RMAT to lasme‑cel, advancing the first off‑the‑shelf CAR‑T into pivotal r/r B‑ALL trial Imugene’s Azer-cel secures FDA Fast Track for CLL/SLL and MZL (Ref) Imugene's Azer-cel (azercabtagene zapreleucel; CD1

Oncofocus Team
Jun 92 min read


Cell and Gene Therapy Updates
February 4th Week, 2025 📝 The US FDA granted RMAT designation for ImmunityBio’s Anktiva (n ogapendekin alfa inbakicept; IL-15 superagonist) and its PD-L1 t-haNK (an allogeneic, a-PD-L1 CAR-NK) for the reversal of lymphopenia in patients receiving SOC chemo/radiotherapy and in Multiply Relapsed Locally Advanced or Metastatic Pancreatic Cancer (Ref 1) ❓ What are the next steps in the development process for Anktiva and PD-L1 t-haNK following the RMAT designation? 📝 UCARsgen

Oncofocus Team
Jun 20, 20251 min read
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