lunedì, 4 maggio 2026

Notizie AIOM – anno XVII

FDA Approves CRC Screening Test for Younger, At-Risk Individuals

Sep 23, 2019 - The FDA has expanded the approval of the noninvasive colorectal cancer (CRC) screening test Cologuard to include eligible at-risk individuals ≥45 years. The updated indication of the at-home stool-based screening assay applies to approximately 19 million ...
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FDA Approves Frontline Daratumumab Regimen for Transplant-Eligible Myeloma

Sep 26, 2019 - The FDA has approved daratumumab in combination with bortezomib, thalidomide, and dexamethasone (VTd) for the treatment of patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT). The approval is based on ...
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Larotrectinib Approved in Europe for NTRK+ Tumors

Sep 23, 2019 - The European Commission has approved larotrectinib for the treatment of adult and pediatric patients with solid tumors that have an NTRK gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result ...
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EU Panel Recommends 4-Week Nivolumab Dosing Schedule in Adjuvant Melanoma

Sep 24, 2019 - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of nivolumab at a flat dosing schedule of either 240 mg over 30 minutes every 2 weeks, or 480 mg infused over 60 minutes every 4 weeks, for the adjuvant ...
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Evaluation of POLE and POLD1 Mutations as Biomarkers for Immunotherapy Outcomes Across Multiple Cancer Types

Immune-checkpoint inhibitor (ICI) therapy, including antibodies targeting programmed cell death protein 1(PD-1), programmed death-ligand 1 (PD-L1), or cytotoxic T-lymphocyte–associated protein 4 (CTLA4), has demonstrated impressive clinical efficacy in controlling ...
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Developing a Highly Specific Biomarker for Germ Cell Malignancies: Plasma miR371 Expression Across the Germ Cell Malignancy Spectrum

Our objective was to evaluate operating characteristics, particularly specificity and positive predictive value (PPV), by mapping plasma miR371 expression to actual clinical events in patients with a history of germ cell tumor. One hundred eleven male patients with a history ...
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27 settembre 2019 – Simposio GCP 2019 – “Dalla ricerca della Qualità alla Qualità della Ricerca”

27 Settembre 2019

Working parties for healthcare professionals and for patients and consumers elect new co-chairs

Sep 25, 2019 - EMA’s Patients' and Consumers' Working Party (PCWP) has re-elected Kaisa Immonen of the European Patients' Forum (EPF) as co-chair and the Healthcare Professionals' Working Party (HCPWP) has elected Ulrich Jäger of the European Hematology Association ...
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27 Settembre 2019

EMA advises companies on steps to take to avoid nitrosamines in human medicines

Sep 26, 2019 - EMA’s human medicines committee (CHMP) is requesting as a matter of precaution that marketing authorisation holders for human medicines containing chemically synthesised active substances review their medicines for the possible presence of nitrosamines ...
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27 Settembre 2019

Change of name of liposomal medicines at high risk of medication errors

Sep 26, 2019 - Marketing authorisation holders of medicines containing liposomal drug delivery systems are requested to submit a variation to change the names of liposomal medicines, but only if there is a high risk of medication errors which would raise concerns regarding ...
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