08/07/2026 New independent-statistician analyses show DCVax-L survival benefit was underestimated New independent-statistician analyses show DCVax-L survival benefit was underestimated (Ref) Northwest Biotherapeutics presented updated survival data from the Phase 3 trial of DCVax®-L (dendritic cell-based vaccine) for glioblastoma (GBM) at the 2026 BNOS meeting. Survival benefit of DCVax-L was likely underestimated in the original trial analysis New analyses used individual pa

October 5th Week, 2025 Regulatory Events 🎯 The EC approved Merck & Co./ MSD's pembrolizumab (anti-PD-1) single agent as a neoadjuvant Tx followed by adjuvant pembrolizumab + RT ± cisplatin after surgery, and then as a single agent for adults with resectable LA SCCHN with PD-L1 CPS ≥1. (Ref 1) ❓ How is this approval expected to impact the treatment algorithm of LA SCCHN? Clinical Events 🔬 Merck & Co./MSD and Eisai US reported that the Phase 3 LITESPARK-011 trial of belzuti

28/10/2025 Alphamab Oncology's JSKN003 received the FDA fast track designation for PROC (Ref) The US FDA granted the fast track designation to Alphamab Oncology's JSKN003 (biparatopic HER2-targeting antibody-drug conjugate) for the treatment of advanced or metastatic platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (PROC). To note, in Sep'24, Alphamab entered a licensing agreement with JMT-Bio Technology (a wholly-ow

October 2nd Week, 2025 Regulatory Events 🎯 The US FDA approved Regeneron's cemiplimab (PD-1 inhibitor) as an adjuvant Tx for adult patients with cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation. (Ref 1) ❓ How is this approval expected to impact the Tx paradigm of this indication? 🎯 The US FDA accepted for Priority Review Orca Bio's BLA seeking approval of Orca-T (allogeneic T-cell immunotherapy) as a Tx of hematological malignancies i

07/10/2025 Precision NeuroMed's cinetredekin besudotox received the FDA orphan drug designation for GBM (Ref) The US FDA granted the orphan drug designation to Precision NeuroMed's cinetredekin besudotox (IL13PE38 ; cytotoxic protein) for the treatment of glioblastoma (GBM). The advanced convection-enhanced delivery (CED) platform delivers therapeutic concentrations of cinetredekin besudotox to tumor-infiltrated regions of the brain Sandeep Kunwar, CEO and Co-Founder, Precisi

September 2nd Week, 2025 Regulatory Events 🎯 The US FDA approved Johnson & Johnson Innovative Medicine's INLEXZO (TAR-200; gemcitabine intravesical system) for the Tx of adults with BCG-unresponsive, non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors (Ref 1) ❓ How is this approval expected to impact the Tx paradigm? 🎯 The US FDA accepted Corcept Therapeutics' NDA for relacorilant (selective glucocorticoid receptor antagonist) as a Tx

08/09/2025 Beyond Air's BA-101 received the Orphan Drug Designation for GBM (Ref) The US FDA granted the Orphan Drug Designation to Beyond Air's BA-101 for the treatment of Glioblastoma (GBM). Amir Avniel, CEO, NeuroNOS: “We are pleased to receive orphan drug designation from the FDA for the treatment of glioblastoma. This is our second orphan drug designation and further highlights our mission to bring targeted therapies to individuals and families affected by rare neurologi

Welcome to the April edition of our CGT Watch newsletter! Autolus’ Aucatzyl’s UK approval; BrainChild Bio’s BCB-276 BTD; Lyell’s LYL314 RMAT designation; TScan’s Ph1 trial update; CERo’s IND approval; CARGO's assets discontinuation; Carisma assessing strategic alternatives; BioNtech co-development option expiration; Caribou Bio restructuring. Stay informed on the latest advancements in the CGT space—subscribe now to receive insightful updates straight to your inbox. Dear R