EMA Recommends Granting a Marketing Authorisation for Azacitidine
It is intended for the maintenance treatment of patients with acute myeloid leukaemia
Oncology News
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EMA Recommends Granting a Conditional Marketing Authorisation for Selumetinib
It is intended for the treatment of paediatric patients with NF1 plexiform neurofibromas
FDA Grants Accelerated Approval to Loncastuximab Tesirine-lpyl for Large B-Cell Lymphoma
Approval is based on findings from the LOTIS-2 study
EMA Recommends Extension of Therapeutic Indications for Nivolumab and Ipilimumab
New indication concerns their combination in the first-line treatment of adult patients with unresectable malignant pleural mesothelioma
Sacituzumab Govitecan Prolongs Survival in Relapsed or Refractory Metastatic Triple Negative Breast Cancer
Primary results of the ASCENT study
EMA Recommends Extension of Therapeutic Indications for Osimertinib
New indication concerns adjuvant treatment in patients with NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations
FDA Grants Accelerated Approval to Dostarlimab-gxly for dMMR Endometrial Cancer
FDA also approved the VENTANA MMR RxDx Panel as a companion diagnostic device for patient selection
Sentinel Lymph Node Biopsy Navigated Neck Dissection Is Not Inferior to Elective Neck Dissection in Early Oral Cancer
Non inferiority demonstrated in terms of the survival rate and superiority shown in terms of neck functionality
Tipifarnib Demonstrates Encouraging Efficacy in Patients with Recurrent and/or Metastatic HNSCC with HRAS Mutations
Results from the KO-TIP-001 study with farnesyltransferase inhibitor in patients with head and neck squamous cell carcinoma
FDA Grants Accelerated Approval to Melphalan Flufenamide for Relapsed or Refractory Multiple Myeloma
Evidence for efficacy is based on the results from the HORIZON study
FDA Approves Nivolumab in Combination with Chemotherapy for Metastatic Gastric Cancer and Oesophageal Adenocarcinoma
Evidence for efficacy is based on the results from the CHECKMATE-649 study
The IGCCCG Update Model Allows Improved and More Granular Individual Prognostic Assessment in Metastatic Non-Seminomatous Germ Cell Tumours
It includes age and lung metastases as additional adverse prognostic factors and uses a single cut-off of LDH at 2.5× ULN