lunedì, 20 marzo 2023

Notizie AIOM – anno XVI n. 684

2019 Medicare Reimbursement Proposed Cuts a Bad Idea for Individuals with Cancer

July 13, 2018 - “ASCO strongly opposes provisions in the 2019 Medicare Physician Fee Schedule (MPFS) proposed rule that could significantly cut cancer care resources that are needed to provide high-quality care to individuals with cancer. “The proposal would ...
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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 July 2018

July 13, 2018 - Following a review of data showing a possible risk of earlier death and an increase in fractures with Radium-223 dichloride, the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) recommended restricting the use of this cancer ...
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13 luglio 2018 – Comunicazione EMA su Radio-223 dicloruro (Bayer AG)

NCI and VA Launch NAVIGATE to Boost Veterans’ Access to Cancer Clinical Trials

July 13, 2018 - Veterans with cancer who receive treatment from the U.S. Department of Veterans Affairs (VA) will now have easier access to clinical trials of novel cancer treatments, thanks to an agreement between the VA and the National Cancer Institute (NCI), part of ...
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FDA Approves Enzalutamide for Nonmetastatic CRPC

July 13, 2018 - The FDA has approved enzalutamide for the treatment of patients with nonmetastatic castration-resistant prostate cancer (CRPC), according to Pfizer and Astellas, the codevelopers of the antiandrogen agent. The approval is based on the phase III PROSPER trial, ...
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FDA Grants Orphan Drug Designation to CPI-613 for Treatment of Burkitt Lymphoma

July 11, 2018 - The U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to CPI-613 for the treatment of Burkitt lymphoma. Burkitt lymphoma is a highly aggressive hematologic B-cell malignancy classically characterized by the overexpression of c-Myc. ...
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Statement from FDA Commissioner Scott Gottlieb, M.D. on agency’s efforts to advance development of gene therapies

July 11, 2018 - Once just a theory, gene therapies are now a therapeutic reality for some patients. These platforms may have the potential to treat and cure some of our most intractable and vexing diseases. The policy framework we construct for how these products should ...
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Cabozantinib in Patients with Advanced and Progressing Hepatocellular Carcinoma

Cabozantinib inhibits tyrosine kinases, including vascular endothelial growth factor receptors 1, 2, and 3, MET, and AXL, which are implicated in the progression of hepatocellular carcinoma and the development of resistance to sorafenib, the standard initial treatment for ...
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Radiologic and Genomic Evolution of Individual Metastases during HER2 Blockade in Colorectal Cancer

Targeting HER2 is effective in 24% of ERBB2 amplified metastatic colorectal cancer; however, secondary resistance occurs in most of the cases. We studied the evolution of individual metastases during treatment to discover spatially resolved determinants of resistance. Circulating ...
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ASCO Clinical Practice Guideline Update: Disease Management for Patients With Advanced HER2-Positive Breast Cancer and Brain Metastases

July 9, 2018 - As reported in the Journal of Clinical Oncology by Naren Ramakrishna, MD, of the University of Florida Health Cancer Center at Orlando Health, and colleagues, ASCO has released a clinical practice guideline update on disease management for patients with advanced ...
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