13/10/2025 Bicara Therapeutics' ficerafusp alfa + pembro received the breakthrough therapy designation for PD-L1 CPS ≥1, R/M SCCHN pts excluding HPV+ve OSCC (Ref) The US FDA granted the breakthrough therapy designation to Bicara Therapeutics' ficerafusp alfa (EGFR x TGF-β bifunctional antibody) in combination with pembrolizumab for the first line treatment of patients with R/M HNSCC whose tumors express PD-L1 CPS ≥1, excluding HPV+ve oropharyngeal squamous cell carcinoma. The

17/07/2025 Johnson & Johnson received Priority Review for TAR-200 from the US FDA in high-risk non-muscle invasive bladder cancer (Ref) The US FDA granted Priority Review to Johnson & Johnson's NDA filed for TAR-200 (intravesical gemcitabine releasing system) for the treatment of BCG-unresponsive, high-risk NMIBC with carcinoma in situ (CIS), with or without papillary tumors. The filing was based on results from the Phase 2b SunRISe-1 trial which demonstrated a CR of 82.4% wi

March 3rd Week, 2025 Regulatory Events 🎯 The US FDA granted traditional approval to Merck & Co./MSD’s pembrolizumab (anti-PD-1) + trastuzumab (anti-HER2) + fluoropyrimidine- and platinum-containing chemo for the first-line treatment of adults with locally advanced, unresectable/metastatic HER2+ve gastric/gastroesophageal junction adenocarcinoma with PD-L1 CPS ≥1 (Ref 1). The regimen was previously granted accelerated approval for this indication in May’21. ❓ Which other re

April 3rd & 4th, 2025 Regulatory Updates 🎯 The UK MHRA granted conditional marketing authorization for Autolus Therapeutics’ Aucatzyl (obecabtagene autoleucel; an autologous, anti-CD19 CAR-T) for the treatment of adult R/R B-ALL patients based on the results from the Ph1/2 FELIX/NCT04404660 study (Ref 1) ❓ In what ways does Aucatzyl’s fast off-rate CD19 binding domain differentiate it from existing CD19 CAR-Ts for B-ALL? 🎯 Lyell Immunopharma received RMAT designation f

March 1st Week, 2025 ⭐ Regulatory Events 🎯 China’s NMPA granted Breakthrough Therapy Designation (BTD) to CARsgen Therapeutics’ satricabtagene autoleucel (satri-cel; CT041; an autologous, anti-CLDN18.2 CAR-T) for the treatment of Claudin18.2-positive ≥third-line G/GEJ cancer (Ref 1) ❓ What are CARsgen’s next steps in advancing satri-cel? Has CARsgen obtained similar designations in other markets? 🎯 The US FDA accepted Bioheng Therapeutics’ IND application for CTD402 (anti-

Dear Readers, Welcome to our inaugural CGT Watch newsletter! We’re excited to bring you monthly highlights on novel targets, innovative therapeutic approaches, and emerging companies in the cell and gene therapy space. Since we’re keen to keep things concise and focused, this issue will exclusively cover cell therapies. We’re using a 45-day window for these highlights; from our next issue onward, we’ll transition to a monthly update schedule. Section 1: Key Monthly Updates 🎯