The FDA has granted a fast track designation to the combination of UV1 with ipilimumab and nivolumab for the treatment of patients with unresectable malignant pleural mesothelioma. This regulatory decision is supported by findings from the phase 2 NIPU trial which is evaluating UV1 in patients with unresectable malignant pleural mesothelioma. … [Read more...]
A Complete Response to Pembrolizumab in Malignant Peritoneal Mesothelioma: A Case Report
Abstract: Malignant peritoneal mesothelioma (MPeM) is a rare cancer of the peritoneum with a poor prognosis and nonspecific clinical course. We discuss a case of MPeM in a 59-year-old male who presented with abdominal pain and distension, without any known previous asbestos exposure. The diagnosis was made after a second biopsy finally confirmed … [Read more...]
Prolia Drug Label Change: Warning for Severe Hypocalcemia in Patients With Chronic Kidney Disease
A January 2024 Prolia drug label change that added a “Black-Box” warning for the “new” Prolia hypocalcemia side effect was announced through this Drug Safety Communication “FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab).” This … [Read more...]
Niraparib plus Dostarlimab in Pleural Mesothelioma or Non-Small Cell Lung Cancer harboring HRR mutations: interim results of the UNITO-001 phase 2 prospective trial
Introduction: Treatment of homologous recombination repair deficient (HRD)-tumours with PARP inhibitors has the potential to further increase tumour immunogenicity, suggesting a synergistic effect with immunotherapy. Here we present the preliminary results of niraparib in combination with dostarlimab for pleural mesothelioma (PM) or non-small cell … [Read more...]
PFAS Update: EPA PFAS CERCLA Designation Takes Effect in 2024
GenX Cases Involving Certain Cancers Filed as PFAS Lawsuits by Individuals May Benefit The United States Environmental Protection Agency (EPA) has designated certain per- and polyfluoroalkyl substances (PFAS) as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). Specifically, the … [Read more...]
Toxicities Potentially Linked to Combination Immunotherapy for Mesothelioma
The [ immunotherapy combination ] of ipilimumab and nivolumab may result in a higher levels of toxicities in patients with unresectable pleural mesothelioma than was reported in the CheckMate 743 trial, according to a recent study published by McNamee et al in the Journal of Thoracic Oncology. Background: Australia has one of the highest rates … [Read more...]
Syfovre Safety Issues Raised In December 2023 JAMA Viewpoint Piece
A December 2023 JAMA Ophthalmology Viewpoint piece about Syfovre safety issues was reported on in a December 7, 2023, Managed Healthcare Executive article, “Independent Assessment of Syfovre Needed, Argues JAMA Ophthalmologist Viewpoint”: An independent panel of retinal specialists and statisticians should assess the clinical trial data for … [Read more...]
New Syfovre Warnings for Retinal Vascular Occlusion and Retinal Vasculitis
A November 2023 label change added new Syfovre warnings for retinal vascular occlusion and retinal vasculitis cases associated with Syfovre injections. With these new Syfovre warnings, it now seems that the retinal vascular occlusion and retinal vasculitis cases associated with Syfovre use are due to the drug itself and not the injection kits, as … [Read more...]
Lung cancer related to onboard asbestos exposure common among naval veterans
Compared with army and air force veterans in the U.K. and Australia, naval veterans more frequently had lung cancers linked to asbestos exposure, according to results published in Scientific Reports. “Asbestos-related diseases are still around,” Richard T. Gun, MBBS, of the school of public health at The University of Adelaide in Australia, told … [Read more...]
Syfovre Vision Side Effects Cases Reported at Ophthalmology Meeting
A Syfovre vision side effects cases presentation was one of the most important at the 2023 Annual Meeting of the American Academy of Ophthalmology (AAO) in San Francisco in early November. William J. Johnson, M.D., of the Wolfe Clinic in Iowa, reported on Syfovre vision side effects cases ranging from hemorrhagic occlusive vasculitis-type … [Read more...]
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