January 2nd Week, 2026 Regulatory Events 🎯  Summit Therapeutics, Inc.  has submitted a biologics license application to the US FDA seeking approval for  Akeso Biopharma  & Summit's ivonescimab (PD-1 x VEGF BsAb) + chemotherapy in second-line or later treatment of patients with EGFR-mutated locally advanced or metastatic non-squamous NSCLC. (Ref 1) ❓ What are the launch timeline estimates for the regimen in this indication?   Special Designations ⭐ The US FDA granted the rege

14/01/2026 Nanjing Leads Biolabs' opamtistomig received the FDA fast track designation for extra-pulmonary neuroendocrine carcinoma Nanjing Leads Biolabs' opamtistomig received the FDA fast track designation for extra-pulmonary neuroendocrine carcinoma ( Ref ) The US FDA granted fast track designation to Nanjing Leads Biolabs' opamtistomig (LBL-024; PD-L1 x 4-1BB bispecific antibody) for the treatment of extra-pulmonary neuroendocrine carcinoma (EP-NEC).  Dr. Charles Cai, CMO

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 res

13/08/2025 Merck's perioperative Keytruda regimen received approval in Canada for resectable HNSCC with PD-L1 CPS ≥1 ( Ref ) Health...

05/08/2025 Immutep received positive feedback from the FDA for the late-stage development of Eftilagimod Alfa in SCCHN ( Ref ) Immutep...

04/08/2025 Alphamab's IND application for JSKN022 was accepted by China's CDE ( Ref ) Alphamab Oncology's IND application for JSKN022...

04/07/2025 Imfinzi has been approved by the EC as a perioperative immunotherapy for muscle-invasive bladder cancer ( Ref ) AstraZeneca’s...

February 4th Week, 2025 📝 The US FDA granted RMAT designation for   ImmunityBio ’s Anktiva (n ogapendekin alfa inbakicept; IL-15...

12/06/2025 MAIA Biotechnology and Roche announce a master clinical supply agreement for hard-to-treat cancer therapies ( Ref ) MAIA...

⭐  BioNTech SE  and  Bristol Myers Squibb  entered into a global strategic partnership with a 50/50 profit/loss split to co-develop and...