EMA Recommends Refusal of a Change to the Marketing Authorisation for Eltrombopag
The change concerned an extension of indications to previously untreated patients with severe aplastic anaemia from 2 years of age
Oncology News
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EMA Recommends Extension of Indications for Pembrolizumab
New indication concerns a combination with axitinib for the first-line treatment of advanced renal cell carcinoma
EMA Recommends Extension of Indications for Elotuzumab
New indication concerns a combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma
Immunogenicity Prediction in BRCA Deficient Breast Cancer
Towards better understanding of the role of immune checkpoint inhibitors in the treatment of this population
New Guidance Documents Lay Foundations in Reporting on Medicines Shortages in the EU
EU network takes steps to improve reporting and communication
EMA Recommends Extension of Indications for Trifluridine/Tipiracil
Changes concern adoption of a new indication for gastric cancer and a change to the existing indication for colorectal cancer
EMA Recommends Extension of Indications for Atezolizumab
New indications concern the first-line treatment of patients with metastatic non-squamous NSCLC who do not have EGFR mutated or ALK positive tumours,and those with extensive-stage SCLC
EMA Recommends Granting a Conditional Marketing Authorisation for Larotrectinib
First ‘histology-independent’ treatment in the EU for solid tumours with a NTRK gene fusion
Updated PORTEC-3 Analysis Shows Improved Survival With Chemoradiotherapy Versus Radiotherapy Alone
Greatest absolute benefit found in patients with stage III endometrial cancer or serous histology, or both
Unfavourable Benefit-Risk Profile of Pembrolizumab Plus Pomalidomide and Dexamethasone in Multiple Myeloma
The results from KEYNOTE-183 study in patients with relapsed or refractory multiple myeloma
EMA Starts Re-examination of Negative Opinion for Glutamine
It was intended for the treatment of sickle cell disease
Towards Lung Cancer Precision Prevention in Chinese Populations
Identification of risk loci and a polygenic risk score for lung cancer in a large-scale prospective cohort study in Chinese populations