16/06/2026 US FDA grants Fast Track to givastomig, in first‑line HER2‑negative metastatic gastric cancer US FDA grants Fast Track to givastomig, in first‑line HER2‑negative metastatic gastric cancer (Ref) ABL Bio & NovaBridge's givastomig, a CLDN18.2 x 4-1BB bispecific antibody, received Fast Track status in combination with nivolumab and chemotherapy for first-line HER2-negative advanced/metastatic gastroesophageal adenocarcinomas that are CLDN18.2 and PD-L1 positive Clinica

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

March 3rd Week, 2026 Regulatory Events 🎯 The US FDA approved Bristol Myers Squibb's nivolumab (anti-PD-1) + doxorubicin + vinblastine + dacarbazine for the treatment of adult and pediatric patients 12 years and older with previously untreated, Stage III/IV cHL. Additionally, the EC approved nivolumab + brentuximab vedotin for the treatment of children 5 years of age and older, adolescents, and adults up to 30 years of age with R/R cHL after one prior line of therapy. (Ref 1)

18/03/2026 Idience's venadaparib received the FDA fast track designation for gastric cancer FluoGuide's FG001 imaging agent received the FDA fast track designation for glioma Idience's venadaparib received the FDA fast track designation for gastric cancer (Ref) The US FDA granted the fast track designation to Idience's venadaparib (PARP inhibitor) for the treatment of gastric cancer. Lee Won-sik, CEO, Idience: “This Fast Track designation is highly meaningful in that the FDA

16/03/2026 AstraZeneca’s perioperative durvalumab regimen received EC approval for early gastric and gastroesophageal cancers Telix resubmitted NDA to the US FDA for TLX101-Px brain cancer imaging candidate AstraZeneca’s perioperative durvalumab regimen received EC approval for early gastric and gastroesophageal cancers (Ref) The EC granted approval to AstraZeneca’s durvalumab (anti-PD-L1) + standard-of-care FLOT chemotherapy for the treatment of adult patients with resectabl

13/02/2026 HanchorBio's HCB101 received the FDA orphan drug designation for gastric cancer HanchorBio's HCB101 received the FDA orphan drug designation for gastric cancer (Ref) The US FDA granted the Orphan Drug Designation to HanchorBio's HCB101 (CD47–SIRPα pathway inhibitor) for the treatment of gastric cancer. The designation covers gastric cancer broadly, including advanced gastric adenocarcinoma in both HER2-positive and HER2-negative subtypes HCB101 is currently being e

January 1st Week, 2026 Clinical Events 🔬 Per primary analysis from the Phase 3 HERIZON-GEA-01 trial, Jazz Pharmaceuticals, BeOne Medicines and Zymeworks Inc.'s zanidatamab (bispecific HER2-directed antibody) + chemo ± BeOne Medicines' tislelizumab (anti-PD-1) met the PFS endpoint as a first-line treatment of HER2+, locally advanced or metastatic gastroesophageal adenocarcinoma. (Ref 1) ❓ What are the current survival benchmarks for this indication? Special Designations ⭐ The

23/12/2025 Alphamab Oncology and 3D (Beijing) Medicines' envafolimab received the FDA orphan drug designation for GC/GEJC SN Bioscience's SNB-101 received the FDA orphan drug designation for GC/GEJC Alphamab Oncology and 3D (Beijing) Medicines' envafolimab received the FDA orphan drug designation for GC/GEJC (Ref) The US FDA granted the orphan drug designation to Alphamab Oncology and 3D (Beijing) Medicines' envafolimab (KN035; subcutaneously injectable PD-L1 inhibitor) for t

12/12/2025 Arcus and Gilead have discontinued the Phase 3 STAR-221 trial of their TIGIT regimen in gastric and esophageal cancers Johnson & Johnson's AKEEGA received FDA approval for BRCA2-mutated CSPC Arcus and Gilead have discontinued the Phase 3 STAR-221 trial of their TIGIT regimen in gastric and esophageal cancers (Ref) The Phase 3 STAR-221 trial of Arcus Biosciences and Gilead's domvanalimab (anti-TIGIT) + zimberelimab (anti-PD-1) + chemotherapy vs nivolumab + chemother

08/12/2025 Chimeric Therapeutics' CHM CDH17 received the FDA orphan drug designation for Gastric Cancer Chimeric Therapeutics' CHM CDH17 received the FDA orphan drug designation for Gastric Cancer (Ref) The US FDA granted the orphan drug designation to Chimeric Therapeutics' CHM CDH17 (CDH17-targeting CAR-T cell therapy) in the treatment of Gastric Cancer. Dr Rebecca McQualter, CEO, Chimeric Therapeutics: “This is a great step forward in the development of CHM CDH17 to serve

17/11/2025 Dewpoint Therapeutics' DPTX3186 received the FDA fast track designation for gastric cancer (Ref) The US FDA granted the fast track designation to Dewpoint Therapeutics' DPTX3186 (oral condensate modulator) for the treatment of gastric cancer. Isaac Klein, CSO and Head of R&D, Dewpoint Therapeutics: “We are honored that the FDA has recognized the urgency of gastric cancer and the promise of our condensate-based approach. DPTX3186 represents a new way of modulating d

29/10/2025 Merck's perioperative Keytruda regimen received approval from the EC for LA SCCHN with PD-L1 CPS ≥1 (Ref) The European Commission (EC) has approved Merck & Co./MSD's pembrolizumab (anti-PD-1) single agent as a neoadjuvant Tx followed by adjuvant pembrolizumab + RT with or without cisplatin after surgery, and then as a single agent for adults with resectable locally advanced SCCHN with PD-L1 CPS ≥1. The approval follows a positive CHMP opinion, and is based on resul

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

12/09/2025 The NDA for Alphamab Oncology and CSPC Pharma's anbenitamab + chemo has been accepted by the NMPA for HER2 +ve GC/GEJC (Ref) China's National Medical Products Administration accepted the NDA for Alphamab Oncology and CSPC Pharma's anbenitamab injection (KN026; anti-HER2 BsAb) in combination with chemotherapy for the treatment of HER2 +ve, locally advanced, recurrent, or metastatic gastric or gastroesophageal junction cancer who have failed at least one prior system

August 4th Week, 2025 Regulatory Events 🎯 Health Canada issued a NOC/c for Iovance Biotherapeutics, Inc.'s lifileucel (autologous TIL therapy) for adult patients with unresectable or metastatic melanoma that has progressed on or after at least one prior systemic therapy including an anti-PD-1, and if BRAF V600 mutant, BRAF inhibitor ± MEK inhibitor, and who have no satisfactory alternative treatment options. (Ref 1) ❓ How is this approval going to impact the Melanoma treat

Health Canada approved Bristol Myers Squibb's nivolumab (Opdivo; anti-PD-1) + ipilimumab (Yervoy; anti-CTLA-4) for the first-line treatment of adult patients with: Unresectable or metastatic MSI-H/dMMR colorectal cancer, and Unresectable or advanced hepatocellular carcinoma

August 1st Week, 2025 Regulatory Events 🎯 AbbVie submitted a sNDA to the US FDA for AbbVie and Roche’s venetoclax (BCL-2 inhibitor) + acalabrutinib (fixed-duration, all-oral combo) in previously untreated patients with chronic lymphocytic leukemia. (Ref 1) ❓ What are the combo’s pros and cons vs approved CLL therapies? Clinical Events 🔬 Eli Lilly and Company’s Phase 3 BRUIN CLL-314 trial of pirtobrutinib (non-covalent, reversible BTK inhibitor) vs ibrutinib (covalent

28/07/2025 sNDA for Akeso and Summit's ivonescimab (PD-1 x VEGF bispecific antibody) + chemotherapy for sqNSCLC accepted by China's NMPA (Ref) The National Medical Products Administration (NMPA) has accepted the sNDA for Akeso and Summit's ivonescimab (PD-1 x VEGF bispecific antibody) + chemotherapy as a first-line treatment for advanced squamous NSCLC. The filing is based on the results from the Phase 3 AK112-306/HARMONi-6 trial, which showed that ivonescimab + chemotherapy

14/07/2025 Henlius’ Ph3 trial of HLX22 combo has dosed the first HER2+ GC patient in the US (Ref) Shanghai Henlius Biotech announced the dosing of the first patient in the US in Phase 3 HLX22-GC-301 international, multicentre trial of HLX22 (anti-HER2) + trastuzumab + chemotherapy vs trastuzumab + chemotherapy ± pembrolizumab as a first-line Tx for HER2+ve, locally advanced or metastatic gastroesophageal junction cancer and gastric cancer The primary endpoints of this study a

24/06/2025 CARsgen Therapeutics submitted a NDA for Satri-cel to China’s NMPA (Ref) CARsgen Therapeutics submitted the New Drug Application (NDA) for satricabtagene autoleucel (satri-cel; an autologous anti-Claudin18.2 CAR-T) to the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the treatment of Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have failed at least two prior