Olumiant (baricitinib) and Xeljanz (tofacitinib) are the two Janus kinase (JAK) inhibitors currently approved by the FDA for the treatment of arthritis and other inflammatory conditions. In September 2021 the FDA announced a JAK inhibitors drug class label change. Specifically, the FDA is requiring revisions to the “Black-Box” warnings for Olumiant … [Read more...]
Imfinzi-Chemo Combo Improves Survival for Mesothelioma
Imfinzi plus platinum-pemetrexed chemotherapy induced survival improvements in patients with previously untreated, unresectable malignant pleural mesothelioma, compared with chemotherapy alone. Treatment with Imfinzi (durvalumab) plus platinum-pemetrexed chemotherapy was associated with improved survival among patients with previously untreated, … [Read more...]
Nivolumab versus placebo in patients with relapsed malignant mesothelioma (CONFIRM): a multicentre, double-blind, randomised, phase 3 trial
Background: No phase 3 trial has yet shown improved survival for patients with pleural or peritoneal malignant mesothelioma who have progressed following platinum-based chemotherapy. The aim of this study was to assess the efficacy and safety of nivolumab [(Opdivo)], an anti-PD-1 antibody, in these patients. Methods: This was a multicentre, … [Read more...]
Immunotherapy combination maintains OS advantage in malignant pleural mesothelioma
The combination of [ Opdivo and Yervoy ] maintained its survival advantage over chemotherapy with at least 3 years of follow-up among patients with unresectable malignant pleural mesothelioma, according to CheckMate 743 study results. Researchers observed the benefit of the first-line immunotherapy regimen despite patients having been off … [Read more...]
GenX Contamination May Be More Toxic Than EPA Initially Thought
Since July 2021, when we posted our last GenX article, “EPA Petitioned to Reconsider Requiring Chemours to Fund PFAS Testing“, it has been determined that GenX contamination in the Cape Fear region may pose more threats than initially thought. These findings come following the Environmental Protection Agency's (EPA) announcement about the … [Read more...]
Gemcitabine with or without ramucirumab as second-line treatment for malignant pleural mesothelioma (RAMES): a randomised, double-blind, placebo-controlled, phase 2 trial
Background: There is a preclinical rationale for inhibiting angiogenesis in mesothelioma. We aimed to assess the efficacy and safety of the anti-VEGFR-2 antibody ramucirumab combined with gemcitabine in patients with pretreated malignant pleural mesothelioma [ as a second-line treatment ]. Methods: RAMES was a multicentre, randomised, … [Read more...]
Two Padcev-induced TEN / SJS Cases Where Patient Died From Their Padcev Side Effects
We continue to monitor the medical literature for any Padcev skin reaction case report involving toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS). In this post, we cover two Padcev-induced TEN / SJS cases where the patient died from their Padcev side effects. We start with a Case Report item published by the Journal of The … [Read more...]
Adding Atezolizumab to Neoadjuvant Cisplatin-Pemetrexed a Feasible Option in Malignant Pleural Mesothelioma
A three-agent neoadjuvant regimen that combines a PD-L1 inhibitor with chemotherapy appears feasible for patients with malignant pleural mesothelioma, according to an ongoing phase I trial. The findings [ about neoadjuvant therapy ] were presented at the International Association for the Study of Lung Cancer virtual World Conference on Lung Cancer, … [Read more...]
Drug Regulator MHRA Imposes More Xeljanz Use Limitations in October 2021
In this Drug Safety Update document, “Tofacitinib (Xeljanz▼): new measures to minimise risk of major adverse cardiovascular events and malignancies”, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) took new regulatory action regarding the Xeljanz risk of cardiovascular events as well as the Xeljanz risk of cancers, or … [Read more...]
Nivo/Ipi Combo Now ‘Standard of Care’ in Mesothelioma
The [ combination immunotherapy consisting ] of nivolumab (Opdivo) and ipilimumab (Yervoy) offers a durable, long-term survival benefit over chemotherapy for patients with unresectable malignant pleural mesothelioma (MPM), confirms a 3-year updated analysis of the CheckMate 743 trial. After 3 years, 23% of patients who received combination … [Read more...]
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