EMA Recommends Extension of Indications for Daratumumab
New indications concern the treatment of patients with multiple myeloma and light chain amyloidosis
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EMA Recommends Extension of Indications for Blinatumomab
New indication concerns the treatment of paediatric patients with high-risk first relapsed Philadelphia chromosome negative CD19-positive B-precursor ALL
NRG1 Fusion–positive Lung Cancers are Molecularly, Pathologically, and Clinically More Heterogeneous than Previously Thought
Findings from the eNRGy1 global multicentre registry
Efficacy and Safety of Adjuvant Nivolumab for High-Risk Muscle-Invasive Urothelial Carcinoma After Radical Surgery
The results of the CheckMate 274 study point to first immune checkpoint inhibitor prolonging the disease-free survival in this setting
FDA Grants Accelerated Approval to Sotorasib for KRAS G12C-mutated NSCLC
FDA also approved the QIAGEN therascreen® KRAS RGQ PCR kit (tissue) and the Guardant360® CDx (plasma) as companion diagnostics
FDA Grants Accelerated Approval to Infigratinib for Metastatic Cholangiocarcinoma
FDA also approved FoundationOne® CDx for selection of patients with FGFR2 fusion or other rearrangement as a companion diagnostic device
Protective HPV Vaccine-Induced Antibody Titres Can Be Detected Up To 12 Years After Vaccination
Findings from a follow-up analysis of data from 2 to 12 years after vaccination
EMA Recommends Extension of Indications for Pembrolizumab
New indication concerns the first-line treatment of advanced oesophageal carcinoma or gastroesophageal junction adenocarcinoma
FDA Grants Accelerated Approval to Amivantamab-vmjw for Metastatic NSCLC with EGFR Exon 20 Insertion Mutations
FDA also approved the Guardant360® CDx as a companion diagnostic
EMA Recommends Extension of Indications for Cemiplimab
New indications concern the treatment of basal cell carcinoma and non-small cell lung cancer
EMA Recommends Extension of Indications for Nivolumab and Ipilimumab
New indication concerns a combination of two drugs for the treatment of dMMR or MSI-H metastatic colorectal cancer
FDA Approves Nivolumab for Resected Oesophageal or Gastro-oesophageal Junction Cancer
Evidence for efficacy is based on the results from the CHECKMATE-577 study