Drugs最新文献

{"title":"Zenocutuzumab: First Approval.","authors":"Hannah A Blair","doi":"10.1007/s40265-025-02155-3","DOIUrl":"10.1007/s40265-025-02155-3","url":null,"abstract":"<p><p>Zenocutuzumab (zenocutuzumab-zbco; BIZENGRI^®), an IgG1 bispecific human epidermal growth factor receptor (HER)2- and HER3-directed antibody, is being developed by Merus for the treatment of solid tumours with neuregulin 1 (NRG1) gene fusions. On 4 December 2024, zenocutuzumab received its first approval in the USA for the treatment of adults with advanced, unresectable or metastatic pancreatic adenocarcinoma or non-small cell lung cancer (NSCLC) harbouring an NRG1 gene fusion with disease progression on or after prior systemic therapy. This article summarizes the milestones in the development of zenocutuzumab leading to this first approval for the second-line treatment of NRG1+ pancreatic adenocarcinoma or NSCLC.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"591-597"},"PeriodicalIF":13.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143491253","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cosibelimab: First Approval.","authors":"Arnold Lee","doi":"10.1007/s40265-025-02164-2","DOIUrl":"https://doi.org/10.1007/s40265-025-02164-2","url":null,"abstract":"<p><p>Cosibelimab (UNLOXCYT; cosibelimab-ipdl) is an anti-PD-L1 antibody developed by Checkpoint Therapeutics for the treatment of advanced cancers, including metastatic or locally advanced cutaneous squamous cell carcinoma (mCSCC or laCSCC). Cosibelimab is the first approved anti-PD-L1 therapy in the USA for the treatment of adults with mCSCC or laCSCC who are not candidates for curative surgery or curative radiation. In contrast to other anti-PD-L1 antibodies, cosibelimab can induce antibody-dependent cell mediated cytotoxicity as it includes a functional F_c domain. This article summarizes the milestones in the development of cosibelimab leading to this first approval for this indication.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":""},"PeriodicalIF":13.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143751565","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Revolutionary Changes in the Management of Lupus Nephritis: Towards De-Glucocorticoid or No-Glucocorticoid.","authors":"Yoshiya Tanaka","doi":"10.1007/s40265-025-02156-2","DOIUrl":"10.1007/s40265-025-02156-2","url":null,"abstract":"<p><p>Glucocorticoids (GCs) possess potent anti-inflammatory and immunosuppressive properties and are used to treat various diseases, including systemic autoimmune rheumatic diseases, rheumatoid arthritis, and systemic lupus erythematosus (SLE). However, GCs are associated with several adverse events and are considered risk factors for infections and cardiovascular disorders; furthermore, their application as therapeutics has changed with recent progress in molecular-targeted therapies. Although GCs have been the mainstay of SLE treatment for more than 50 years, the latest European Alliance of Association for Rheumatology recommendations for the management of SLE in 2023 has significantly relegated the use of GCs and recommended that these be used as \"bridging therapy\" during periods of SLE disease activity. They also recommended the use of GC pulse therapy followed by relatively low doses of GCs even in patients with high disease-activity lupus nephritis, with a focus on the appropriate use of hydroxychloroquine, immunosuppressive drugs, and biological agents. This combination is essential for improving renal survival, minimizing flares, and reducing the side effects of GC. The GC dose was tapered to < 5 mg/day of prednisolone within half a year, maintained for 3 years, and then discontinued with the concomitant use of combination therapies. In contrast to non-renal SLE, the development of more potent molecular targeted therapies for lupus nephritis is required.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"447-455"},"PeriodicalIF":13.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143476366","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Tasurgratinib Succinate: First Approval.","authors":"Yvette N Lamb","doi":"10.1007/s40265-025-02153-5","DOIUrl":"10.1007/s40265-025-02153-5","url":null,"abstract":"<p><p>Tasurgratinib succinate (TASFYGO^®; Eisai Co., Ltd.) is an orally active, small molecule inhibitor of fibroblast growth factor receptors (FGFRs) 1, 2, and 3 being developed for the treatment of solid tumors, including cholangiocarcinoma (i.e., bile duct cancer) and breast cancer. Tasurgratinib succinate received its first approval on 24 September 2024 in Japan, for the treatment of FGFR2 fusion-positive unresectable biliary tract cancer that has progressed after chemotherapy. The approval was based on the positive results of an open-label, single-arm, multicenter, phase II study conducted in Japan and China. This article summarizes the milestones in the development of tasurgratinib succinate leading to this first approval for biliary tract cancer.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"585-590"},"PeriodicalIF":13.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143540580","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Iparomlimab and Tuvonralimab: First Approval.","authors":"Susan J Keam","doi":"10.1007/s40265-025-02160-6","DOIUrl":"https://doi.org/10.1007/s40265-025-02160-6","url":null,"abstract":"<p><p>Iparomlimab and tuvonralimab (^®) is a bifunctional combination of anti-programmed death receptor-1 (PD-1)/anti-cytotoxic T lymphocyte-associated protein-4 (CTLA-4) monoclonal antibodies (mAbs) being developed by Qilu Pharmaceutical Co., Ltd for the treatment of advanced, solid, malignant tumours. In September 2024, iparomlimab and tuvonralimab was granted conditional approval (based on surrogate endpoints) for the treatment of patients with recurrent or metastatic cervical cancer who have failed previous platinum-based chemotherapy. This article summarizes the milestones in the development of iparomlimab and tuvonralimab leading to this first approval for the treatment of patients with recurrent or metastatic cervical cancer who have failed previous platinum-based chemotherapy.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":""},"PeriodicalIF":13.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143751583","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Emerging Immunotherapies for Disease Modification of Type 1 Diabetes.","authors":"Timothy P Foster, Brittany S Bruggeman, Michael J Haller","doi":"10.1007/s40265-025-02150-8","DOIUrl":"10.1007/s40265-025-02150-8","url":null,"abstract":"<p><p>Type 1 diabetes mellitus (T1DM) is characterized by the progressive, autoimmune-mediated destruction of β cells. As such, restoring immunoregulation early in the disease course is sought to retain endogenous insulin production. Nevertheless, in the more than 100 years since the discovery of insulin, treatment of T1DM has focused primarily on hormone replacement and glucose monitoring. That said, immunotherapies are widely used to interdict autoimmune and autoinflammatory diseases and are emerging as potential therapeutics seeking the preservation of β-cell function among those with T1DM. In the past 4 decades of diabetes research, several immunomodulatory therapies have been explored, culminating with the US Food and Drug Administration approval of teplizumab to delay stage 3 (clinical) onset of T1DM. Clinical trials seeking to prevent or reverse T1DM by repurposing immunotherapies approved for other autoimmune conditions and by exploring new therapeutics are ongoing. Collectively, these efforts have the potential to transform the future of diabetes care. We encapsulate the past 40 years of immunotherapy trials, take stock of our successes and failures, and chart paths forward in this new age of clinically available immune therapies for T1DM.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"457-473"},"PeriodicalIF":13.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11949705/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143052018","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety and Longevity of Intraocular Pressure Control After Bimatoprost Implant Administration: Interim Analysis of a Phase 3b Clinical Trial (TRITON).","authors":"Steven M Silverstein, Francesco Oddone, Miriam Kolko, Christian K Brinkmann, William C Christie, Amanda K Bicket, Petrus N J Gous, Jan Luebke, Jyotsna Maram, Ashley Nguyen, E Randy Craven, Yongjia Pu, Jenny Jiao, Marina Bejanian, Michael R Robinson","doi":"10.1007/s40265-025-02154-4","DOIUrl":"10.1007/s40265-025-02154-4","url":null,"abstract":"<p><strong>Background: </strong>Bimatoprost implant 10 µg is an intracameral, biodegradable implant that slowly releases bimatoprost to lower intraocular pressure (IOP). This study was designed to evaluate safety and the duration of the IOP-lowering effect after single and as-needed repeat administration of the bimatoprost implant in patients with open-angle glaucoma (OAG) and ocular hypertension (OHT).</p><p><strong>Patients and methods: </strong>This study is an interim analysis of an ongoing, prospective, open-label, multicenter study in patients with OAG or OHT who are inadequately managed with topical IOP-lowering medication for reasons other than efficacy. IOP-lowering rescue treatment is allowed if implant retreatment criteria are not met. The primary endpoint is time to retreatment/rescue after the initial implant administration analyzed with the Kaplan-Meier method. Key safety measures include treatment-emergent adverse events (TEAEs) and reading-center evaluation of central corneal endothelial cell density (CECD). Analysis of data collected through 15 September 2023 focused on outcomes after a single or two implants.</p><p><strong>Results: </strong>In total, 441 patients received the 10-µg bimatoprost implant in the study eye on day 1 (cycle 1), 179 patients received a second administration (cycle 2), and 378 patients had at least 12 months of follow-up data available. The median time (95% confidence interval) from the first administration to a second administration or rescue was 392 (369, 485) days; the probability of not requiring retreatment or rescue by day 360 was 57.5%. A second implant administration similarly provided a long duration of IOP control. The baseline mean (standard error, SE) IOP was 25.6 (0.14) mmHg; the mean (SE) change from baseline IOP in unrescued eyes after a single administration was - 7.5 (0.21) mmHg at week 24 and - 6.4 (0.28) mmHg at month 12. Conjunctival hyperemia, typically associated with the administration procedure, was the most common ocular TEAE (cycle 1, 14.3%; cycle 2, 12.8%). Mean (SE) percentage change in CECD from baseline at 12 months after administration was - 4.3 (0.81)% in cycle 1 and - 8.5 (2.22)% in cycle 2. The cycle 1 implant was no longer visible or ≤ 25% of initial size in 66.3% and 94.3% of study eyes at months 12 and 24, respectively.</p><p><strong>Conclusions: </strong>In this interim analysis based on available data, the IOP-lowering effect of the initial administration of the 10-µg bimatoprost implant was well maintained for > 1 year in most patients. Results after a second administration were comparable. The safety profile of initial and repeat administration was acceptable.</p><p><strong>Trial registry: </strong>ClinicalTrials.gov identifier NCT03850782; registered 20 February 2019.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"557-570"},"PeriodicalIF":13.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11947067/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143476367","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Classic Psychedelics for the Treatment of Depression: Potential Benefits and Challenges.","authors":"Sharmin Ghaznavi, Sarah G Richter","doi":"10.1007/s40265-025-02172-2","DOIUrl":"https://doi.org/10.1007/s40265-025-02172-2","url":null,"abstract":"<p><p>There has been a recent resurgence in research on psychedelics as therapeutic agents for psychiatric conditions. This leading article outlines the studies to date of classic psychedelic treatments for treatment-resistant depression and major depression, including psilocybin, ayahuasca, dimethyltryptamine (DMT), and O-methyl-bufotenine (5-Me-O DMT). We discuss the potential of expanding treatment options for depression based on the data available, as well as the difficulties and limitations of research on psychedelics that make assessing that potential more challenging.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":""},"PeriodicalIF":13.0,"publicationDate":"2025-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143699918","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Current Drug Treatment for Acute and Recurrent Pericarditis.","authors":"Aldo Bonaventura, Davide Santagata, Alessandra Vecchié, Antonio Abbate","doi":"10.1007/s40265-025-02169-x","DOIUrl":"https://doi.org/10.1007/s40265-025-02169-x","url":null,"abstract":"<p><p>Pericarditis is the most frequent pericardial disease and presents with a relatively benign course when treated according to guideline-directed therapies at first presentation. Recurrence is the most frequent complication and may occur more frequently after a first episode, in patients with autoimmune etiology, in patients who received glucocorticoids, or after rapid (i.e., within 1 month) tapering of anti-inflammatory drugs. The therapeutic armamentarium for pericarditis includes high-dose nonsteroidal anti-inflammatory drugs (NSAIDs) that are tapered rapidly once symptoms are controlled. Colchicine is necessary to both relieve symptoms and reduce the rate of recurrences and is continued for at least 3-6 months. Low- to moderate-dose glucocorticoids are reserved for patients with a first recurrence for which NSAIDs and colchicine failed and/or who have an autoimmune disorder, with a slow tapering. Interleukin-1 blockers-anakinra, rilonacept, and goflikicept-are used as a third-line option in patients who cannot come off glucocorticoids or as second-line therapy after NSAIDs and colchicine in patients with contraindications to glucocorticoids or in those with high-risk features (i.e., multiple episodes, markedly elevated inflammatory markers, or extensive abnormalities at pericardial imaging) in whom treatment with glucocorticoids is unlikely to succeed.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":""},"PeriodicalIF":13.0,"publicationDate":"2025-03-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143676965","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction: From Prospective Evaluation to Practice: Model-Informed Dose Optimization in Oncology.","authors":"Bram C Agema, Birgit C P Koch, Ron H J Mathijssen, Stijn L W Koolen","doi":"10.1007/s40265-025-02174-0","DOIUrl":"10.1007/s40265-025-02174-0","url":null,"abstract":"","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":""},"PeriodicalIF":13.0,"publicationDate":"2025-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143662859","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}