FDA Approves Diagnostic Tool for Pembrolizumab Combo in Endometrial Cancer
The US FDA has cleared the OncoMate MSI Dx Analysis System as a companion diagnostic to guide pembrolizumab-based combination therapy in advanced endometrial cancer. The PCR-based assay determines microsatellite instability (MSI) status in tumour tissue, with support from Merck, developer of pembrolizumab and lenvatinib.
Progression-Free Survival (PFS) | 15/11/2025 | By Dineshwori
US FDA Grants Priority Review for Enhertu + Pertuzumab in HER2+ Metastatic Breast Cancer
The US FDA has granted Priority Review to Enhertu + Pertuzumab for HER2+ metastatic breast cancer, following DESTINY-Breast09 trial results showing a 44 percent reduction in risk of disease progression or death and over three years’ median Progression-Free Survival (PFS), positioning it as a potential new first-line standard of care.
Progression-Free Survival (PFS) | 25/09/2025 | By Dineshwori
Anbenitamab Set to Lead as First Bispecific mAb in China's HER2+ Gastric Cancer Market: GlobalData
China’s NMPA has accepted Alphamab Oncology’s NDA for KN026 (Anbenitamab), which could become the first bispecific mAb for HER2-positive gastric and GEJ cancer, according to GlobalData.
Progression-Free Survival (PFS) | 25/09/2025 | By Dineshwori
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