In our last article, we reported on the current FDA investigation of an Ocaliva safety signal which, although it began in May 2020, only became public knowledge in October. The best we can tell, it is a possible Ocaliva liver toxicity issue that is the subject of this Ocaliva FDA investigation. Now we have some additional information about some … [Read more...]
A multicentre randomised phase III trial comparing pembrolizumab vs single-agent chemotherapy for advanced pre-treated malignant pleural mesothelioma: the European Thoracic Oncology Platform (ETOP 9-15) PROMISE-meso trial
Background: Malignant pleural mesothelioma (MPM) is an aggressive malignancy characterized by limited treatment options and a poor prognosis. At relapse after platinum-based chemotherapy, single-agent chemotherapy is commonly used and single-arm trials of immune-checkpoint inhibitors have demonstrated encouraging activity. Patients and … [Read more...]
Current Ocaliva Liver Safety FDA Evaluation Started Back in May 2020
In October 2020 we first learned about a "new" drug safety issue for Ocaliva -- although it apparently has been on the FDA's radar since at least May 2020. It seems a possible Ocaliva liver-related side effects risk has attracted scrutiny, and there is an Ocaliva liver safety FDA evaluation underway. It was this October 9, 2020, Endpoints News … [Read more...]
FDA Approves Drug Combination for Treating Mesothelioma
[On October 02, 2020], the U.S. Food and Drug Administration approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the first-line treatment of adults with malignant pleural mesothelioma that cannot be removed by surgery. This is the first drug regimen approved for mesothelioma in 16 years and the second FDA-approved systemic … [Read more...]
Beovu-associated Endophthalmitis is “New” for Beovu Eye Drug Safety Issue of Vision Loss
In this article, we will look at the Beovu-associated endophthalmitis and Beovu-associated retinal detachment aspects of the Beovu eye drug safety issue of vision loss. New warnings for these vision-related side effects were added in June 2020 when Novartis revised the Prescribing Information for Beovu. In the Beovu drug label, or “Full … [Read more...]
Durvalumab with first-line chemotherapy in previously untreated malignant pleural mesothelioma (DREAM): a multicentre, single-arm, phase 2 trial with a safety run-in
Background: There is a strong unmet need to improve systemic therapy in mesothelioma. Chemotherapy with cisplatin and pemetrexed improves survival in malignant pleural mesothelioma, and immune checkpoint inhibitors are an emerging treatment in this disease. We aimed to evaluate the activity of durvalumab, an anti-PD-L1 antibody, given during … [Read more...]
Beovu Use Continues Despite Ongoing Beovu-associated Inflammation Investigation
A summary of the Beovu-associated inflammation safety issue is presented in this July 2020 Journal of VitreoRetinal Diseases Research Article, “Occlusive Retinal Vasculitis Following Intravitreal Brolucizumab”. From the Abstract for this item we get these details about the current Beovu safety issue under investigation: Conclusions: … [Read more...]
Safety of Beovu Update: Study Results Announcement by Novartis and Beovu Label Change in Europe
A September 2020 announcement by Novartis about recent Beovu study results had an emphasis on the safety of Beovu. However, this is understandable in view of a February 2020 notification issued by the American Society of Retina Specialists (ASRS) which raised questions about the safety of Beovu. We get the following from this September 14, … [Read more...]
FDA clears IND application for CAR T-cell therapy for advanced mesothelioma
The FDA cleared an investigational new drug application for ATA2271, a chimeric antigen receptor T-cell therapy [ or CAR T-cell therapy ] for the treatment of advanced mesothelioma, according to the agent’s manufacturer. ATA2271 (Atara Biotherapeutics) is an autologous CAR T-cell therapy that targets the mesothelin antigen expressed on the … [Read more...]
FDA Belviq Recall Decision Came After Safety Data Review Found Excess Cancers Risks
In this FDA staff article, “Cancer risk associated with lorcaserin — The FDA’s review of the CAMELLIA-TIMI 61 trial”, which was published by the New England Journal of Medicine (NEJM), the early 2020 FDA Belviq recall decision was explained. Essentially, this FDA action after a careful analysis of Belviq safety data that revealed excess … [Read more...]
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