Drugs最新文献

{"title":"Current and Emerging Biomarkers and Surrogate Endpoints in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD).","authors":"Mariam Alamgir, Aalam Sohal, Kris V Kowdley","doi":"10.1007/s40265-026-02369-z","DOIUrl":"10.1007/s40265-026-02369-z","url":null,"abstract":"<p><p>Metabolic dysfunction-associated steatotic liver disease (MASLD), formerly known as non-alcoholic fatty liver disease (NAFLD), is a prevalent condition affecting 25-30% of the global population and is closely linked to obesity, type 2 diabetes, and other cardiometabolic risk factors. Although liver biopsy remains the gold standard for diagnosis, its invasive nature has prompted a shift toward non-invasive biomarkers for disease assessment, staging, and monitoring. Multiple non-invasive biomarkers have been studied or are currently under investigation to assess both fibrosis and steatosis among patients with MASLD. This review aims to summarize the current literature on emerging and established biomarkers for MASLD, focusing on their roles in detecting inflammation, fibrosis, metabolic dysfunction, and steatosis, including imaging-based surrogate endpoints and composite biomarker panels.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1645-1660"},"PeriodicalIF":14.7,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148955073","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":"Lenacapavir: A Review in HIV Pre-Exposure Prophylaxis.","authors":"Hannah A Blair","doi":"10.1007/s40265-026-02368-0","DOIUrl":"10.1007/s40265-026-02368-0","url":null,"abstract":"<p><p>Lenacapavir [YEZTUGO^® (USA); YEYTUO^® (EU)] is the first twice‑yearly long‑acting injectable option to be approved for HIV pre‑exposure prophylaxis (PrEP). As a potent HIV capsid inhibitor, lenacapavir disrupts multiple stages of the viral replication cycle. Its slow absorption and long half‑life permit administration as a subcutaneous (SC) injection once every 6 months. Lenacapavir is indicated for PrEP to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing ≥ 35 kg who are at risk for HIV-1 acquisition. In two large phase III clinical trials, lenacapavir demonstrated efficacy in preventing HIV acquisition across diverse populations, including cisgender women, cisgender gay, bisexual, and other men, transgender women, transgender men, and gender-nonbinary persons who have sex with partners assigned male at birth. HIV incidence with lenacapavir was significantly lower than the background HIV incidence and the HIV incidence with daily oral PrEP (emtricitabine/tenofovir disoproxil fumarate). Adherence to lenacapavir was consistently high across both trials. Lenacapavir was generally well tolerated, with mostly mild or moderate injection‑site reactions (ISRs) that declined in frequency over time. With its convenient twice‑yearly dosing schedule and SC route of administration, lenacapavir represents a valuable addition to the current portfolio of HIV PrEP options.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1723-1733"},"PeriodicalIF":14.7,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148722276","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":"Management of Multiple Sclerosis: Incorporating Recent Advances in Pathophysiology and Diagnosis to Guide Treatment Strategies.","authors":"Moein Amin, Kaitlyn N Palmer, Amjad Samara, Jeffrey A Cohen","doi":"10.1007/s40265-026-02391-1","DOIUrl":"https://doi.org/10.1007/s40265-026-02391-1","url":null,"abstract":"<p><p>Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disorder of the central nervous system for which more than 20 disease-modifying therapies (DMTs) are currently available. Recent advances in diagnostic criteria, biomarker development, and understanding of disease biology have challenged traditional phenotype-based treatment paradigms and created new opportunities for individualized therapeutic strategies. The 2024 McDonald diagnostic criteria expand the biological definition of MS through incorporation of advanced MRI biomarkers, thereby supporting earlier diagnosis and potentially earlier treatment initiation. Aging influences both disease pathobiology and treatment risk-benefit balance, contributing to reduced focal inflammatory activity, increased progression, diminished regenerative capacity, and greater susceptibility to infections and comorbidities. These observations have important implications for treatment initiation, sequencing, escalation, de-escalation, and discontinuation. Current monitoring strategies remain centered on relapses, disability measures, and MRI lesion activity, but each has important limitations. Emerging imaging and fluid biomarkers, including brain and spinal cord atrophy metrics, neurofilament light chain, glial fibrillary acidic protein, and paramagnetic rim lesions, may improve biological stratification and therapeutic decision making, although further validation is needed. Safety considerations vary substantially across DMT classes. Real-world data have advanced our understanding of long-term risks, particularly with B-cell-depleting therapies. Novel therapeutic approaches in development are intended to more effectively target compartmentalized central nervous system inflammation and progression biology while potentially reducing systemic immunosuppression. As a result of these factors, MS management is evolving.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":""},"PeriodicalIF":14.7,"publicationDate":"2026-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149105780","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":"GLP-1 Receptor Agonists in Heart Failure: A Systematic Review and Meta-analysis with Phenotype-Specific Effects and Dual Analytical Frameworks.","authors":"Yahui Yuan, Chun Chen, Xiuming Li, Jingyi Guo, Qiaoyun Liu, YuPing Lin, Lu Sun, Guanjie Fan","doi":"10.1007/s40265-026-02380-4","DOIUrl":"https://doi.org/10.1007/s40265-026-02380-4","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Although glucagon-like peptide-1 receptor agonists (GLP-1 RAs) reduce cardiovascular risk in patients with type 2 diabetes mellitus (T2D), evidence in heart failure (HF) has expanded across diverse trial populations and HF phenotypes but remains fragmented. We therefore performed an integrated systematic review and meta-analysis to evaluate the effects of GLP-1 RAs across the spectrum of HF using complementary trial-level and phenotype-based analyses.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;PubMed, Embase, and Web of Science were systematically searched for studies published from inception to August 10, 2025. To provide an integrated assessment across heterogeneous HF populations, treatment effects were evaluated using dual analytical frameworks: trial-level analyses according to study design (dedicated HF with preserved ejection fraction [HFpEF] trials, HF with reduced ejection fraction [HFrEF] trials, and HF subgroups from cardiovascular outcome trials [CVOTs]) and phenotype-based analyses according to left ventricular ejection fraction (HFpEF vs HFrEF using a pragmatic threshold of 40%). A prespecified targeted analysis was conducted to specifically assess the efficacy of semaglutide. The primary outcomes were major adverse cardiovascular events (MACE), and the secondary outcomes included hospitalization for HF (HHF), the composite of cardiovascular death or any worsening HF events, cardiovascular death alone, and all-cause mortality. Pooled hazard ratios (HRs) with 95% confidence intervals (CIs) were calculated using random‑effects models.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;This meta-analysis included 14 trials, with a pooled total of 15,882 patients with HF. In phenotype‑based analyses for HFpEF, GLP‑1 RAs significantly reduced MACE (HR 0.79; 95% CI 0.66-0.94; p = 0.010), HHF (HR 0.48; 95% CI 0.27-0.85; p = 0.012), the composite of cardiovascular death or worsening HF (HR 0.57; 95% CI 0.37-0.89; p = 0.013), and all‑cause mortality (HR 0.75; 95% CI 0.62-0.89; p = 0.001). In contrast, in HFrEF, no significant reductions were observed for HHF, the composite of cardiovascular death or worsening HF, all-cause mortality, or MACE, although a reduction in cardiovascular death was noted (HR 0.71; 95% CI 0.54-0.95; p = 0.019). Trial-level analyses showed that cardiovascular benefits were primarily observed in HF subgroups from CVOTs, including reductions in MACE (HR 0.82; 95% CI 0.73-0.92; p = 0.001), cardiovascular death (HR 0.88; 95% CI 0.77-1.00; p = 0.05) and myocardial infarction (MI)/non-fatal MI (HR 0.84; 95% CI 0.70-1.00; p = 0.046). Semaglutide showed benefits in HHF and the composite of cardiovascular death or worsening HF events predominantly among overweight or obese patients with HFpEF. GLP-1 RAs also improved functional capacity and quality of life in HFpEF.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;GLP-1 RAs were associated with favorable cardiovascular and HF-related outcomes in HFpEF, predominantly among overweight or ob","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":""},"PeriodicalIF":14.7,"publicationDate":"2026-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149059169","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":"Personalized Treatment of Hemophilia: Matching Therapies to Patient Needs in a Rapidly Evolving Landscape.","authors":"Timea Szanto, Riitta Lassila","doi":"10.1007/s40265-026-02386-y","DOIUrl":"https://doi.org/10.1007/s40265-026-02386-y","url":null,"abstract":"<p><p>The therapeutic landscape of hemophilia, a rare inherited bleeding disorder, has rapidly evolved, introducing several novel modalities: extended half-life (EHL) coagulation factor concentrates, non-factor therapies, hemostasis-rebalancing agents, and gene therapy. These advances have improved clinical outcomes by reducing bleeding and treatment burden. However, individualizing treatment in routine practice has become more complex. This narrative review aims to provide a practical summary of available treatment options for pharmacologists, policymakers, and other readers who are not hemophilia specialists. A practical decision framework integrates available data with the clinical indication (regular prophylaxis, management of breakthrough bleeding, and perioperative care), patient-specific modifiers (age, lifestyle, inhibitor status, venous access, joint phenotype, comorbidities, and thrombosis risk). Drug therapies are discussed according to clinical evidence, including pivotal phase 3 trials, long-term extension studies, real-world data, and late-stage development programs. Factor replacement remains critical for hemostatic control during acute bleeding, surgery, and other interventions where predictable and measurable exposure is needed, whereas non-factor and rebalancing therapies provide low-burden prophylactic alternatives with distinct safety profiles and monitoring challenges. Direct comparisons between treatment classes are limited, making treatment individualization essential. Gene therapy has demonstrated more durable outcomes in hemophilia B than in hemophilia A. This review supports shared decision-making and individualized treatment selection in modern hemophilia care. While clinical trial evidence is limited by the scarcity of head-to-head comparisons and incomplete integration of real-world determinants, registry data collection will be essential.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":""},"PeriodicalIF":14.7,"publicationDate":"2026-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149037124","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":"Camizestrant: First Approval.","authors":"Arnold Lee","doi":"10.1007/s40265-026-02385-z","DOIUrl":"https://doi.org/10.1007/s40265-026-02385-z","url":null,"abstract":"<p><p>Camizestrant (Etcamah^®) is an orally available, potent selective estrogen receptor degrader (SERD) and complete estrogen receptor (ER) α antagonist being developed by AstraZeneca for the treatment of breast cancer. It received its first approval in the United Arab Emirates (UAE) in May 2025. At the time of writing, the drug had been subsequently approved in Saudi Arabia, Japan, the EU, Canada, the UK and the USA. In patients with ER-positive and human epidermal growth factor receptor 2 (HER2)-negative breast cancer with a detectable ESR1 mutation, switching to camizestrant while continuing the same CDK4/6 inhibitor significantly prolonged progression-free survival in comparison with continuing treatment with an aromatase inhibitor in combination with a CDK4/6 inhibitor. This article summarizes the milestones in the development of camizestrant leading to this first approval for the treatment of adults with locally advanced or metastatic hormone receptor positive (HR+), HER2-negative breast cancer with an ESR1 gene mutation that emerges during first-line hormonal therapy, in combination with CDK4/6 inhibitors.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":""},"PeriodicalIF":14.7,"publicationDate":"2026-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149037118","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":"Efficacy and Safety of IGF-1 Receptor Inhibitors for Thyroid Eye Disease: Systematic Review and Meta-analysis of Randomized Controlled Trials.","authors":"Haiyang Zhang, Zixiang Zhang, Ting Lu, Sien Ping Chew, Huijie Zhang, Yinwei Li, Terry J Smith, Huifang Zhou","doi":"10.1007/s40265-026-02388-w","DOIUrl":"https://doi.org/10.1007/s40265-026-02388-w","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background and objective: &lt;/strong&gt;Insulin-like growth factor-1 receptor (IGF-1R) inhibitors represent the first and currently only US Food and Drug Administration (FDA)-approved disease-modifying therapy for thyroid eye disease (TED). Understanding their efficacy and safety is essential for treatment decision-making. A comprehensive analysis of randomized controlled trial (RCT) data of these drugs is necessary for defining reliably improved outcomes and commonly observed treatment-related adverse events. In this study, we aimed to evaluate the efficacy and safety profiles of IGF-1R inhibitors for treatment of TED as evidenced by RCTs.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This systematic review and meta-analysis was prospectively registered in the International Prospective Register of Systematic Reviews (PROSPERO; CRD420251141789) and conducted according to Preferred Reporting Items for Systematic review and Meta-Analysis (PRISMA) guidelines. PubMed, Embase, Web of Science, Cochrane Library, and EBSCO were searched through 10 December 2025. Eligible studies were RCTs comparing IGF-1R inhibitors with placebo in TED. Two reviewers independently performed study selection, data extraction, and quality assessment using the Cochrane risk of bias tool. Fixed- or random-effects models, selected according to the degree of statistical heterogeneity, were used to estimate pooled risk ratios (RRs) and mean differences (MDs), with subgroup, meta-regression, and sensitivity analyses exploring heterogeneity.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;A total of 669 patients participating in 7 RCTs were included from 957 articles screened. These include studies evaluating teprotumumab, IBI311, and veligrotug. Regarding primary outcomes, IGF-1R inhibitors improved proptosis significantly (RR = 7.71, 95% CI 5.04-11.79, P &lt; 0.001) and increased overall response (RR = 8.74, 95% CI 5.61-13.62, P &lt; 0.001). Secondary outcome analysis revealed a significant improvement with IGF-1R inhibitors versus placebo, including achieving clinical activity score (CAS) of 0 or 1 (RR = 3.19, 95% CI 2.40-4.24, P &lt; 0.001), diplopia (RR = 1.95, 95% CI 1.52-2.50, P &lt; 0.001), least squares mean (LSMean) change in proptosis (MD = - 2.22 mm, 95% CI - 2.45 to - 1.99 mm, P &lt; 0.001) and LSMean change in quality of life (MD = 10.48, 95% CI 6.95-14.00, P &lt; 0.001). Pooled adverse-event rate was higher in the active treatment group (RR = 1.15, 95% CI 1.06-1.24, P &lt; 0.001). Subgroup analysis and meta-regression identified disease activity as a significant predictor of proptosis reduction, with greater efficacy in acute active TED, while an exploratory subgroup difference in diplopia response was observed between trials conducted in predominantly white and predominantly East Asian populations (P(Qint) = 0.027).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;IGF-1R inhibitors outperformed placebo across multiple efficacy outcomes. These findings confirm their robust efficacy in TED, particularly in active disease. G","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":""},"PeriodicalIF":14.7,"publicationDate":"2026-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149037108","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":"Pharmacotherapy of Irritable Bowel Syndrome with Constipation in Children: An Update on Clinical Progress and Successes.","authors":"Maria Giovanna Puoti, Anna O J Oorthuys, Nicolaas Koen Vermeijden, Marc A Benninga, Osvaldo Borrelli","doi":"10.1007/s40265-026-02376-0","DOIUrl":"https://doi.org/10.1007/s40265-026-02376-0","url":null,"abstract":"<p><p>Irritable bowel syndrome with constipation is a prevalent disorder of gut-brain interaction in children and adolescents, associated with chronic abdominal pain, altered bowel habits, reduced quality of life, and a significant healthcare burden. Despite a wide range of therapeutic approaches, treatment responses remain suboptimal, highlighting the need for effective, evidence-based pharmacological options. This review summarizes current and emerging pharmacological therapies for pediatric irritable bowel syndrome with constipation, with a focus on their mechanisms of action, efficacy, and safety. Traditional treatments such as dietary fiber, probiotics, antispasmodics, laxatives, prokinetics, antidepressants, antibiotics, and antihistamines are reviewed, emphasizing the limited and often inconsistent evidence supporting their use for pain relief and overall symptom improvement. Particular attention is given to newer agents approved for adults with irritable bowel syndrome with constipation, including secretagogues (linaclotide, plecanatide, and lubiprostone) and the retainagogue tenapanor, with a detailed discussion of their pharmacological properties and clinical trial data. Linaclotide is currently the only medication approved by the U.S. Food and Drug Administration for the treatment of irritable bowel syndrome with constipation in children aged 7 years or older. While other novel agents have shown promise in adults, pediatric data remain limited or unavailable. Overall, although pharmacological treatment options for pediatric irritable bowel syndrome with constipation are expanding, high-quality, pediatric specific clinical trials are still needed to guide safe and effective management.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":""},"PeriodicalIF":14.7,"publicationDate":"2026-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149024143","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":"Vaccination for Gonorrhoea: Where Are We Now, and What Comes Next?","authors":"Valentin A Slesarenko, Sharareh Eskandari, Evgeny A Semchenko, Kate L Seib","doi":"10.1007/s40265-026-02387-x","DOIUrl":"https://doi.org/10.1007/s40265-026-02387-x","url":null,"abstract":"<p><p>Gonorrhoea, caused by Neisseria gonorrhoeae, is a common bacterial sexually transmitted infection and a major global health burden, with more than 80 million new cases estimated annually. There is currently no licensed vaccine, and increasing antimicrobial resistance has renewed the urgency of vaccine development. However, vaccines licensed to prevent invasive meningococcal disease, caused by the closely related bacterium Neisseria meningitidis, may provide cross-protection against N. gonorrhoeae. Observational studies have associated outer membrane vesicle-containing serogroup B meningococcal vaccines with reduced gonorrhoea rates, with estimated effectiveness of approximately 30%. The four-component meningococcal group B vaccine (4CMenB) contains antigens with gonococcal homologues and induces cross-reactive immune responses in both humans and animal models. These findings have supported the implementation of targeted 4CMenB immunisation programmes for people at high risk of gonorrhoea in the UK and Galicia, Spain. However, the recently reported GoGoVax trial and other randomised controlled trials in men who have sex with men (MSM) at high risk of infection have not demonstrated protection against gonorrhoea. Differences in study design, populations, exposure intensity, endpoints and residual confounding may explain the divergence between observational and randomised findings. Ongoing trials in other populations, together with post-implementation surveillance in the UK, will provide important evidence regarding the effectiveness of 4CMenB in different settings. Several gonococcus-specific vaccine candidates are also advancing through preclinical and clinical development. Future progress will benefit from validated correlates of protection, improved understanding of protective mucosal immunity across different anatomical sites and evaluation of vaccine efficacy across diverse populations and exposure settings.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":""},"PeriodicalIF":14.7,"publicationDate":"2026-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149024183","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":"Anbenitamab: First Approval.","authors":"Hannah A Blair","doi":"10.1007/s40265-026-02382-2","DOIUrl":"https://doi.org/10.1007/s40265-026-02382-2","url":null,"abstract":"<p><p>Anbenitamab (Ennituo^®), a bispecific IgG monoclonal antibody targeting human epidermal growth factor receptor 2 (HER2), is being developed by Alphamab Oncology for the treatment of various solid tumours (including gastric cancer and breast cancer). Anbenitamab received its first approval in China on 27 May 2026. Anbenitamab, in combination with chemotherapy, is approved for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have previously received at least one trastuzumab-containing therapy. This article summarizes the milestones in the development of anbenitamab leading to this first approval for gastric or GEJ cancer.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":""},"PeriodicalIF":14.7,"publicationDate":"2026-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148955023","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}