01/12/2025 Cullinan Therapeutics' CLN-049 received the FDA fast track designation for R/R Acute Myeloid Leukemia Astellas Pharma and Pfizer's Type II variation application for perioperative enfortumab vedotin + pembro has been valiated by the EMA Cullinan Therapeutics' CLN-049 received the FDA fast track designation for R/R Acute Myeloid Leukemia ( Ref ) The US FDA granted the fast track designation to Cullinan Therapeutics' CLN-049 (FLT3 x CD3 bispecific T cell engager) for

21/11/2025 Pembrolizumab + enfortumab vedotin received the FDA approval for MIBC ( Ref ) The US FDA granted approval to Merck & Co./MSD pembrolizumab (anti-PD-1; both IV and SC formulations) in combination with Pfizer and Astellas' enfortumab vedotin (Nectin-4 ADC) as a neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for the treatment of adult patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemothera

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

13/10/2025 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. T

08/10/2025 Regeneron's cemiplimab has been approved by the US FDA for the adjuvant Tx of CSCC ( Ref ) The US FDA approved Regeneron...

19/09/2025 Merck & Co/MSD received positive EU CHMP Opinions for perioperative pembrolizumab regimen in SCCHN, and for subcutaneous...

Highlights from the CHMP Sep 2025 Meeting are out! New Biosimilars 💊  Teva Pharmaceuticals ' Degevma (RANKL inhibitor; denosumab...

04/09/2025 Eli Lilly and Company's olomorasib in combination with Keytruda received the FDA Breakthrough Therapy designation...

25/08/2025 Quest Diagnostics' Haystack MRD® test received the Breakthrough Device Designation from the FDA for colorectal cancer ( Ref )...

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

12/08/2025 Perioperative pembrolizumab + enfortumab vedotin significantly improved EFS, OS and pCR in cisplatin-ineligible MIBC ( Ref )...

11/08/2025 IO Biotech's Cylembio + pembrolizumab demonstrated clinical improvement in PFS as a first-line treatment of Melanoma, but...

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

30/07/2025 Phase 3 COSTAR Lung trial of dostarlimab + docetaxel ± cobolimab failed to meet the OS endpoint in previously treated NSCLC (...

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

15/05/2025 Another TIGIT agent fails as iTeos and GSK terminate the belrestotug development program based on disappointing NSCLC and...

29/04/2025 ALX Oncology’s Phase 2 ASPEN-03 & ASPEN-04 trials failed to meet the primary endpoint of ORR ( Ref 1 ) ALX Oncology hit with a...

The first-line metastatic Melanoma market is currently dominated by immune checkpoint inhibitors—BMS' Opdivo + Yervoy, Opdualag, Opdivo,...

Bladder cancer is the most common malignancy of the urinary tract. As of 2022, Bladder Cancer had an incidence of 614,298 patients...

Esophageal cancer is the fourteenth most commonly diagnosed cancer and the eighth leading cause of cancer-related death worldwide. The...