NICE Issues Technology Appraisal Guidance on Abemaciclib with an Aromatase Inhibitor
Recommendations concern previously untreated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer
Oncology News
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Biosimilars have a fascinating story of development and understanding it is crucial for widespread adoption
Biosimilars have a fascinating story of development, says Rosa Giuliani, and understanding it is crucial for widespread adoption.
EMA Recommends Approval of Pazenir for the Treatment of Metastatic Breast Cancer and NSCLC
Pazenir is a generic of Abraxane which has been authorised in the EU since 2008
EMA Recommends Granting a Conditional Marketing Authorisation for Lorlatinib
It is intended for treatment of patients with ALK-positive advanced NSCLC previously treated with other ALK tyrosine kinase inhibitors
EMA Recommends an Extension of Indications for Olaparib
New indication concerns treatment of adult patients with germline BRCA1/2-mutations, who have HER2-negative locally advanced or metastatic breast cancer
FDA Approves New Formulation of Herceptin for Subcutaneous Use
Approval is based on results from two randomised trials, HannaH and SafeHER
FDA Approves Trifluridine/Tipiracil for Recurrent, Metastatic Gastric and Gastro-oesophageal Junction Adenocarcinoma
Approval is based on results from the TAGS trial
FDA Approves Pembrolizumab for Adjuvant Treatment of Melanoma
Approval is based on results from the EORTC1325/KEYNOTE‑054 study
Neoadjuvant PD-1 Blockade in Glioblastoma
Evaluation of changes in the tumour immune microenvironment
Role of Big Data for Evaluation and Supervision of Medicines in the EU
Summary report of the Heads of Medicines Agencies – EMA Joint Big Data task force
Two Health Consortia to Develop a Detailed Feasibility Proposal for Europe’s Next €1-billion Science Projects
LifeTime and RESTORE among shortlisted projects
NICE Develops a Medtech Innovation Briefing on Axumin
Axumin is a radiopharmaceutical agentfor functional imaging of prostate cancer recurrence