We continue to monitor the medical literature for developments relevant to the important drug safety issue of drug-induced liver injury (DILI). This medical journal article, “ACG Clinical Guideline: Diagnosis and Management of Idiosyncratic Drug-Induced Liver Injury”, appeared in The American Journal of Gastroenterology (AJC) May 2021 … [Read more...]
Nivolumab prolongs PFS, OS in relapsed malignant mesothelioma
Nivolumab significantly prolonged PFS and OS compared with placebo for patients with [ relapsed mesothelioma ], according to findings presented at International Association for the Study of Lung Cancer World Conference on Lung Cancer. “Mesothelioma is predominately a disease that is not suitable for surgery and is one for which chemotherapy has … [Read more...]
Ocrevus PML Case Report: Patient Used Ocrevus, Only, Without Prior Tysabri or Gilenya Use
The primary source for this Ocrevus PML case report is a JAMA Neurology Brief Report item dated March 16, 2021, “Progressive Multifocal Leukoencephalopathy in a Patient With Progressive Multiple Sclerosis Treated With Ocrelizumab Monotherapy”. From the Abstract for that medical journal article we take this excerpt: Conclusions and … [Read more...]
Alterations in BAP1 Are Associated with Cisplatin Resistance through Inhibition of Apoptosis in Malignant Pleural Mesothelioma
Purpose: The clinical standard treatment for patients with malignant pleural mesothelioma (MPM) includes a cisplatin-based chemotherapy, leading to reduction of tumor size in only a minority of patients. Predicting response to chemotherapy in patients with MPM by using a genetic marker would, therefore, enable patient … [Read more...]
BIA-ALCL Current Recommendations and Potential Future FDA Guidance Changes
History of BIA-ALCL In 2011, the Food and Drug Administration (FDA) reported 34 cases worldwide of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), bringing this unique disease into the public eye for the first time. Since then, BIA-ALCL has been recognized internationally as a distinct type of cancer, and prompted the 2019 … [Read more...]
Possible FDA Advisory Committee Meeting for Xeljanz, Olumiant, and Rinvoq in Future
Based on these several recent developments, we expect that there will be an FDA Advisory Committee Meeting for Xeljanz, Olumiant, and Rinvoq in the months to come. The focus of such will likely be these adverse drug events and side effects related to the JAK inhibitors class of drugs: Heart AttacksMyocardial Infarction (MI)Strokes — Ischemic / … [Read more...]
Incidence of mesothelioma and asbestosis by occupation in a diverse workforce
Objective: We sought to characterize detailed patterns of mesothelioma and asbestosis incidence in the workforce as part of an occupational disease surveillance program in Ontario, Canada. Methods: The Occupational Disease Surveillance System (ODSS) cohort was established using workers’ compensation claims data and includes 2.18 million workers … [Read more...]
There Will Be No Belviq Generic Drugs After Belviq Drug Recall in 2020
There has been some further FDA action regarding Belviq which is related to the 2020 Belviq drug recall that was due to an increased risk of cancer. This further FDA action means there will be no Belviq generic drugs after the Belviq drug recall in 2020. This February 26, 2021 Notice item, “Determination That BELVIQ (Lorcaserin Hydrochloride) … [Read more...]
Efficacy and safety of pembrolizumab in patients with advanced mesothelioma in the open-label, single-arm, phase 2 KEYNOTE-158 study
Background: Malignant pleural mesothelioma (MPM) has few treatment options. [ Keytruda (pembrolizumab) ] showed preliminary clinical benefit in programmed death ligand 1 (PD-L1)-positive MPM. We evaluated the efficacy and safety of [ Keytruda (pembrolizumab) ] monotherapy in patients with previously treated MPM irrespective of PD-L1 status in … [Read more...]
Anti-Mesothelin CAR T cell therapy for malignant mesothelioma
AbstractMalignant mesothelioma (MM) is a treatment-resistant tumor originating in the mesothelial lining of the pleura or the abdominal cavity with very limited treatment options. More effective therapeutic approaches are urgently needed to improve the poor prognosis of MM patients. Chimeric Antigen Receptor (CAR) T cell therapy has emerged as a … [Read more...]
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