Notizie AIOM – anno XV
FDA Grants Atezolizumab Priority Review for Second Bladder Cancer Indication
9 gennaio 2017 - The FDA has granted a priority review to a supplemental new drug application (sNDA) for the use of the PD-L1 inhibitor atezolizumab (Tecentriq) in cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma (mUC) as a frontline ...Leggi tutto
Results From the Phase III Randomized Trial of Onartuzumab Plus Erlotinib Versus Erlotinib in Previously Treated Stage IIIB or IV Non–Small-Cell Lung Cancer: METLung
The phase III OAM4971g study (METLung) examined the efficacy and safety of onartuzumab plus erlotinib in patients with locally advanced or metastatic non–small-cell lung cancer selected by MET immunohistochemistry whose disease had progressed after treatment with a ...Leggi tutto
Systematic versus on-demand early palliative care: A randomised clinical trial assessing quality of care and treatment aggressiveness near the end of life
Early palliative care (EPC) in oncology has shown sparse evidence of a positive impact on patient outcomes, quality of care outcomes and costs. Data for this secondary analysis were taken from a trial of 207 outpatients with metastatic pancreatic cancer randomly assigned ...Leggi tutto
Trastuzumab Emtansine With or Without Pertuzumab Versus Trastuzumab Plus Taxane for Human Epidermal Growth Factor Receptor 2–Positive, Advanced Breast Cancer: Primary Results From the Phase III MARIANNE Study
Trastuzumab and pertuzumab are human epidermal growth factor receptor 2 (HER2)–targeted monoclonal antibodies, and trastuzumab emtansine (T-DM1) is an antibody–drug conjugate that combines the properties of trastuzumab with the cytotoxic activity of DM1. T-DM1 ...Leggi tutto
Rovalpituzumab tesirine, a DLL3-targeted antibody-drug conjugate, in recurrent small-cell lung cancer: a first-in-human, first-in-class, open-label, phase 1 study
Rovalpituzumab tesirine is a first-in-class antibody-drug conjugate directed against delta-like protein 3 (DLL3), a novel target identified in tumour-initiating cells and expressed in more than 80% of patients with small-cell lung cancer. We aimed to assess the safety and ...Leggi tutto
FDA Grants Priority Review for the sNDA for Regorafenib in the Second-Line Systemic Treatment of Liver Cancer
5 gennaio 2017 - On January 4, the U.S. Food and Drug Administration (FDA) granted Priority Review status for the supplemental New Drug Application (sNDA) for regorafenib (Stivarga) tablets for the second-line systemic treatment of patients with hepatocellular carcinoma ...Leggi tutto
FDA Grants JCAR017 Breakthrough Designation for Non-Hodgkin Lymphoma
21 dicembre 2016 - JCAR017 has received an FDA breakthrough therapy designation for the treatment of patients with relapsed/refractory, aggressive large B-cell non-Hodgkin lymphoma (NHL), according to Juno and Celgene, the codevelopers of the CD19-targeted CAR T-cell therapy. ...Leggi tutto