Drugs[JOURNAL]
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200 papers
The Tailored Biosimilar Approach: Expectations and Requirements.
Guillen E, Barry S, Jost N … +9 more , Ekman N, Knippel V, Kuhlmann-Gottke J, Maier J, Weise M, Laslop A, Anour R, van Zandbergen G, Kirsch-Stefan N
Drugs · 2025 May · PMID 40169518 · Full text
Regulatory approval of biosimilar medicines currently requires a combination of physicochemical and functional testing, pharmacokinetic data, and clinical efficacy studies (CES). In this article, we discuss the tailored...
Regulatory approval of biosimilar medicines currently requires a combination of physicochemical and functional testing, pharmacokinetic data, and clinical efficacy studies (CES). In this article, we discuss the tailored biosimilar approach, which represents an evolution in regulatory thinking by moving away from the default requirement for CES in biosimilar approval. We explore how physicochemical and functional data can be predictive for clinical performance and address the limitations of CES for regulatory decision-making. We argue that, in most cases, the combination of a robust package of physicochemical and functional testing, with appropriately designed pharmacokinetic studies provides sufficient evidence to establish biosimilarity. Additionally, we provide our perspective on the requirements, expectations, and exceptions for future biosimilar approvals, outlining specific scenarios where additional clinical evidence may be necessary. These include cases where the mechanism of action is unknown or poorly characterized, when product heterogeneity cannot be adequately characterized, or where relevant safety or immunogenicity concerns arise with the reference product or biosimilar candidate. Finally, we aim to clarify the remaining concerns surrounding the tailored biosimilar approach, providing insights into the potential to streamline biosimilar development and regulatory approval.
Efficiency and Safety of Noninvasive and Intravesical Therapy for Adult Neurogenic Lower Urinary Tract Dysfunction: A Systematic Review and Network Meta-analysis of Randomized Controlled Trials.
Wang Q, Li C, Long Y … +6 more , Cao B, Lu Y, Luo G, Huang Y, Huang G, Huang H
Drugs · 2025 May · PMID 40167970 · Publisher ↗
BACKGROUND: Neurogenic lower urinary tract dysfunction (NLUTD), a complex abnormality caused by multiple neurologic disorders, is a serious threat to patients' prognosis and quality of life. However, benefit and safety f...
BACKGROUND: Neurogenic lower urinary tract dysfunction (NLUTD), a complex abnormality caused by multiple neurologic disorders, is a serious threat to patients' prognosis and quality of life. However, benefit and safety for various treatments are inconsistent. The aim of the current study was to investigate the available trials of adult NLUTD treatments and provide valuable insights for clinical practice. METHODS: The data sources were Medline, Embase, and Cochrane databases up to 31 December 2023. A Bayesian network meta-analysis was conducted with randomized controlled trials in patients who were diagnosed with NLUTD, reporting clinical symptoms and urodynamic data. The main outcomes were incontinence episodes frequency (IEF) and maximum cystometric capacity (MCC). Secondary outcomes included frequency, maximum detrusor pressure, bladder compliance, volume of involuntary detrusor contraction, voided volume, incontinence, quality of life, and adverse events. RESULTS: A total of 54 articles were eligible, evaluating 28 treatments and 4478 patients for efficacy and safety. Compared with the control group, the oxybutynin instillation demonstrated a mean reduction in IEF of - 2.65 episodes (95% confidence interval [CI]: - 4.64 to - 0.67), with a surface under the cumulative ranking curve (SUCRA) value of 85.8%. Botulinum toxin trigone-combined injection resulted in a reduction of -2.30 episodes (95% CI: -3.23 to - 1.44; SUCRA 84.2%). Additionally, intravesical therapies significantly increased MCC: oxybutynin instillation (mean 227.75 mL, 95% CI 147.00 to 311.42, SUCRA 99.1%) and BTX300U (mean 147.88 mL, 95% CI 100.45-190.32, SUCRA 83.2%). Botulinum toxin injection emerged as the preferred option for improving most urodynamic outcomes and quality of life. However, the incidence of adverse events associated with intravesical injections was higher compared with oral medications and other noninvasive therapies. The three types of botulinum toxins (onabotulinum toxin, abobotulinum toxin, and incobotulinum toxin) demonstrated consistent efficacy in treating both IEF and MCC. Individual studies were sequentially excluded for analysis of network stability. Most results from the alternative networks were consistent with the original analysis, although specific trials influenced certain therapy rankings. CONCLUSIONS: Overall, oxybutynin instillation and intravesical botulinum toxin injection demonstrated significant advantages in improving symptoms and urodynamic parameters. Our findings support intravesical treatment as a safe and effective option, provided that patients are fully informed about their treatment choices. Clinically, intravesical therapies, oral medications, nerve stimulation, and other treatments should be integrated into shared decision-making processes, while some options require further research to bolster the supporting evidence.
Cosibelimab: First Approval.
Lee A
Drugs · 2025 May · PMID 40167969 · Publisher ↗
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 (m...
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 domain. This article summarizes the milestones in the development of cosibelimab leading to this first approval for this indication.
Iparomlimab and Tuvonralimab: First Approval.
Keam SJ
Drugs · 2025 May · PMID 40167968 · Publisher ↗
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 Phar...
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.
Tafolecimab, a Third Monoclonal Antibody for PCSK9 as the Novel Lipid-Lowering Drug Around the World: A Narrative Review.
Liu HH, Li S, Li JJ
Drugs · 2025 May · PMID 40167967 · Publisher ↗
Tafolecimab, a fully human monoclonal antibody targeting proprotein convertase subtilisin/kexin type 9 (PCSK9), represents a significant therapeutic advancement in the management of hypercholesterolemia and has been appr...
Tafolecimab, a fully human monoclonal antibody targeting proprotein convertase subtilisin/kexin type 9 (PCSK9), represents a significant therapeutic advancement in the management of hypercholesterolemia and has been approved for use in the Chinese population. Elevated low-density lipoprotein cholesterol (LDL-C) is a major risk factor for atherosclerotic cardiovascular disease, and traditional treatments often fall short due to challenges such as statin intolerance. Clinical trials have demonstrated that tafolecimab can effectively reduce LDL-C levels, achieving reductions of over 60% in many patients. It also improves other lipid parameters, including lipoprotein(a) [Lp(a)], non-high-density lipoprotein cholesterol (non-HDL-C), and apolipoprotein B (ApoB). It has a favorable safety profile, primarily characterized by mild to moderate adverse events. The long-acting formulation of tafolecimab enables less frequent dosing, thereby promoting compliance. As cardiovascular diseases continue to escalate globally, tafolecimab holds promise not only for patients in China but also for broader international applications, representing a critical advancement in the evolving landscape of lipid-lowering therapies.
Classic Psychedelics for the Treatment of Depression: Potential Benefits and Challenges.
Ghaznavi S, Richter SG
Drugs · 2025 May · PMID 40128500 · Publisher ↗
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...
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.
Current Drug Treatment for Acute and Recurrent Pericarditis.
Bonaventura A, Santagata D, Vecchié A … +1 more , Abbate A
Drugs · 2025 May · PMID 40119189 · Full text
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 complicatio...
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.
Correction: From Prospective Evaluation to Practice: Model-Informed Dose Optimization in Oncology.
Agema BC, Koch BCP, Mathijssen RHJ … +1 more , Koolen SLW
Drugs · 2025 May · PMID 40108070 · Full text
Abstract loading — click title to view on PubMed.
Zanidatamab: First Approval.
Keam SJ
Drugs · 2025 May · PMID 40108069 · Publisher ↗
Zanidatamab (ZIIHERA; zanidatamab- hrii), a bi-specific antibody targeting two non-overlapping epitopes of the human epidermal growth factor receptor 2 (HER2) protein, is being developed by Jazz Pharmaceuticals and BeiGe...
Zanidatamab (ZIIHERA; zanidatamab- hrii), a bi-specific antibody targeting two non-overlapping epitopes of the human epidermal growth factor receptor 2 (HER2) protein, is being developed by Jazz Pharmaceuticals and BeiGene Ltd under license agreements from Zymeworks Inc., the developer of the molecule, for the treatment of HER2-expressing solid tumours. This article summarizes the milestones in the development of zanidatamab leading to this first accelerated approval for use in adults with previously treated, unresectable or metastatic HER2+ (IHC3+) biliary tract cancer (BTC), as detected by an FDA-approved test.
Renal Safety Assessment of Lipid-Lowering Drugs: Between Old Certainties and New Questions.
Tramontano D, Bini S, Maiorca C … +10 more , Di Costanzo A, Carosi M, Castellese J, Arizaj I, Commodari D, Covino S, Sansone G, Minicocci I, Arca M, D'Erasmo L
Drugs · 2025 Jun · PMID 40106181 · Full text
Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in patients with chronic kidney disease (CKD). Quantitative and qualitative changes in plasma lipoprotein profiles are frequently associated wi...
Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in patients with chronic kidney disease (CKD). Quantitative and qualitative changes in plasma lipoprotein profiles are frequently associated with CKD and represent a significant risk factor for CVD in patients with CKD. Guidelines from the European Society of Cardiology and the European Atherosclerosis Society classify CKD as a condition with high or very high cardiovascular risk and set specific low-density lipoprotein cholesterol targets. Conventional lipid-lowering therapies (LLTs), such as statins, ezetimibe, and fibrates, can control CKD-associated dyslipidemia and, to some extent, prevent major atherosclerotic events in patients with CKD, but their use in clinical practice presents challenges because of the potential renal safety concerns. In recent years, novel therapies with the ability to lower both low-density lipoprotein cholesterol and triglycerides have been introduced to the market (e.g., proprotein convertase subtilisin/kexin type 9 inhibitors, bempedoic acid, lomitapide, volanesorsen) to improve our ability to control lipid abnormalities. However, their impact on kidney functionality has not been fully elucidated. The aim of this review was to examine the renal safety profiles of various LLTs, with special reference to novel medications, and to highlight important considerations and guidance for the use of these medications in overt CKD or in patients with some degree of renal function impairment. We underscore the lack of a comprehensive understanding of kidney safety, particularly for novel LLT therapies, and strongly emphasize the importance of future dedicated research to fully assess the safety and efficacy of these agents in patients with kidney abnormalities.
Safety of Anti-osteoarthritis Medications: A Systematic Literature Review of Post-marketing Surveillance Studies.
Honvo G, Lengelé L, Alokail M … +3 more , Al-Daghri N, Reginster JY, Bruyère O
Drugs · 2025 Apr · PMID 40095377 · Publisher ↗
BACKGROUND: Several meta-analyses of phase 3 randomized controlled trials (RCTs) were published in 2019, reassessing the safety of most anti-osteoarthritis (OA) medications, mainly on the basis of data from full safety r...
BACKGROUND: Several meta-analyses of phase 3 randomized controlled trials (RCTs) were published in 2019, reassessing the safety of most anti-osteoarthritis (OA) medications, mainly on the basis of data from full safety reports. The current systematic review (SR) intends to provide complementary insights into the safety of anti-OA medications, using evidence from post-marketing safety surveillance studies. METHODS: The review protocol was registered with PROSPERO database (registration no. CRD42021227872). We followed the Cochrane methodology for SRs of interventions and comprehensively searched the Medline, CENTRAL, Scopus and TOXLINE databases from inception to November 2023, to include all post-marketing safety surveillance studies on any anti-OA medications. The outcomes of this SR were any adverse events (AEs) reported in the included studies. RESULTS: The literature search yielded 16,990 studies, of which 59 articles were ultimately included in the review. Most studies investigated non-steroidal anti-inflammatory drugs (NSAIDs, 27 studies, 28 reports) and intra-articular hyaluronic acid (IAHA, 16 studies). Symptomatic slow-acting drugs for osteoarthritis (SYSADOAs) were assessed in seven studies (one of which also assessed NSAIDs), and corticosteroid injections in four studies, while opioids and "herbal mixtures and other compounds" each were investigated respectively in three and two studies. Most of the studies were cohort studies (n = 44), others were case reports or case series (n = 12), RCTs (n = 2 reports of the same trial), or a case-control study (n = 1). The most commonly reported AEs with NSAIDs from cohort (sample sizes varied between 129 and 22,938 patients), RCT (21,645 patients with OA), and case-control (174 cases and 926 control patients with OA) studies were gastrointestinal (GI) and/or cardiovascular (CV) AEs, with specific AEs varying with individual NSAIDs. Where comparisons between NSAIDs were made, the overall literature shows a better or similar safety profile for celecoxib (at a daily dose of 200 mg, where dosage was reported) compared with other NSAIDs in regards to GI, CV and renal events. Other anti-OA medications with most common AEs reported from cohort studies were: IAHA (injection site pain); diacerein (GI AEs and reddish urine); avocado-soybean unsaponifiables (GI AEs); non-pharmaceutical-grade glucosamine and chondroitin (allergic reactions, GI disorders); opioids (hip fracture associated with long-term tramadol use among older adults; GI and nervous system disorders with hydrocodone); corticosteroid injections (increased risk of OA progression); herbal mixtures and other compounds (GI AEs). There were case reports or case series of specific AEs with various anti-OA medications that require further investigations in well-designed cohort studies before any definitive conclusions can be reached. CONCLUSIONS: This SR confirms previous evidence on the safety of anti-OA medications from meta-analyses of phase 3 RCTs. Beyond the evidence here reported, the limitations of this research highlight the urgent need of a reporting guideline for post-marketing safety surveillance studies. Importantly, real-life safety surveillance of anti-OA medications should be strengthened with large cohort studies with control groups, and results should be disaggregated by disease populations for drugs common to several conditions.
Stapokibart: First Approval.
Shirley M
Drugs · 2025 May · PMID 40095376 · Publisher ↗
Stapokibart (Kangyueda; ) is a humanised IgG4 monoclonal antibody targeted against the interleukin (IL)-4 receptor alpha subunit (IL-4Rα). By binding IL-4Rα, stapokibart blocks the binding by (and subsequent signalling o...
Stapokibart (Kangyueda; ) is a humanised IgG4 monoclonal antibody targeted against the interleukin (IL)-4 receptor alpha subunit (IL-4Rα). By binding IL-4Rα, stapokibart blocks the binding by (and subsequent signalling of) IL-4 and IL-13, two type 2 cytokines. Stapokibart is being developed by KeyMed Biosciences for the treatment of atopic dermatitis and other type 2 inflammatory diseases. In September 2024, stapokibart received its first approval, in China, for use in the treatment of moderate-to-severe atopic dermatitis in adults whose disease is poorly controlled by, or not suitable for, topical medications. Subsequently, stapokibart additionally received approval in China for use in the treatment of chronic rhinosinusitis with nasal polyps (December 2024) and for the treatment of seasonal allergic rhinitis (February 2025). Stapokibart is also under clinical evaluation for use in the treatment of moderate-to-severe asthma and chronic obstructive pulmonary disease, and prurigo nodularis. This article summarises the milestones in the development of stapokibart leading to this first approval for moderate-to-severe atopic dermatitis.
Olezarsen: First Approval.
Syed YY
Drugs · 2025 Apr · PMID 40074987 · Publisher ↗
Olezarsen (TRYNGOLZA™) is a first-in-class, GalNAc-conjugated antisense oligonucleotide being developed by Ionis Pharmaceuticals for the treatment of familial chylomicronaemia syndrome (FCS) and severe hypertriglyceridae...
Olezarsen (TRYNGOLZA™) is a first-in-class, GalNAc-conjugated antisense oligonucleotide being developed by Ionis Pharmaceuticals for the treatment of familial chylomicronaemia syndrome (FCS) and severe hypertriglyceridaemia. It binds to apoC-III mRNA, promoting its degradation and lowering serum apoC-III protein levels. This action lowers triglyceride levels by enhancing the clearance of plasma triglyceride-rich lipoproteins such as chylomicrons and very-low-density lipoproteins. GalNAc conjugation improves hepatocyte uptake, which helps localise oligonucleotide treatment to the liver; this enables lower dosing, reduced injection volume and frequency, potentially reducing the risk of adverse events such as thrombocytopenia. Olezarsen received its first approval in the USA on 19 December 2024 under priority review as an adjunct to diet to reduce triglycerides in adults with FCS. This article summarizes the milestones in the development of olezarsen leading to this first approval for FCS.
Update on the Treatment of Chronic Spontaneous Urticaria.
Kolkhir P, Fok JS, Kocatürk E … +4 more , Li PH, Okas TL, Marcelino J, Metz M
Drugs · 2025 Apr · PMID 40074986 · Full text
Chronic spontaneous urticaria (CSU) is a mast cell-mediated skin disease that presents with wheals, angioedema, or both for more than 6 weeks. Less than 10% of patients have complete control of their CSU (the main goal o...
Chronic spontaneous urticaria (CSU) is a mast cell-mediated skin disease that presents with wheals, angioedema, or both for more than 6 weeks. Less than 10% of patients have complete control of their CSU (the main goal of CSU treatment) with second generation H1-antihistamines, the first-line treatment. About 70% of patients with antihistamine-refractory CSU do not reach complete control with omalizumab, the second-line treatment. Novel therapies are especially needed for patients with mast cell-activating immunoglobulin (Ig)G autoantibodies (autoimmune CSU) associated with nonresponse or late response to omalizumab. Furthermore, there is a lack of disease-modifying treatments that induce long-term CSU remission after drug withdrawal. Several emerging treatments can address these unmet needs including Bruton tyrosine kinase inhibitors, e.g., remibrutinib and rilzabrutinib; anti-KIT monoclonal antibodies, e.g., barzolvolimab; and anti-cytokine therapies, e.g., dupilumab. In clinical trials, 30-31%, 28-32%, and 38-51% of patients with CSU showed complete response to treatment with dupilumab (phase 3, week 24), remibrutinib (phase 3, week 24), and barzolvolimab (phase 2, week 12), respectively. The most common adverse events were injection site reactions for dupilumab (12%), respiratory tract infections (11%), headache (6%), and petechiae (4%) for remibrutinib and changes in hair color (14%), neutropenia / decreased neutrophil count (9%) and skin hypopigmentation (1%) for barzolvolimab. This review provides an update on the current state of development of treatments for CSU.
Revumenib: First Approval.
Syed YY
Drugs · 2025 Apr · PMID 40072775 · Publisher ↗
Revumenib (Revuforj) is an oral, first-in-class menin inhibitor developed by Syndax Pharmaceuticals for the treatment of KMT2A-rearranged (KMT2Ar) acute leukaemia, NPM1-mutated (NPM1m) acute myeloid leukaemia (AML) and s...
Revumenib (Revuforj) is an oral, first-in-class menin inhibitor developed by Syndax Pharmaceuticals for the treatment of KMT2A-rearranged (KMT2Ar) acute leukaemia, NPM1-mutated (NPM1m) acute myeloid leukaemia (AML) and solid tumours. The interaction between menin and the KMT2A protein complex leads to aberrant gene expression, driving leukaemogenic transcription. By blocking this interaction, revumenib promotes differentiation and exerts antileukaemic activity in KMT2Ar acute leukaemias and other menin inhibition-sensitive leukaemias. Revumenib received its first approval on 15 November 2024 in the USA for the treatment of relapsed or refractory (R/R) acute leukaemia with a KMT2A translocation in adult and paediatric patients 1 year and older. This article summarizes the milestones in the development of revumenib leading to this first approval.
Tasurgratinib Succinate: First Approval.
Lamb YN
Drugs · 2025 Apr · PMID 40035947 · Publisher ↗
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 chol...
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.
Zenocutuzumab: First Approval.
Blair HA
Drugs · 2025 Apr · PMID 39994106 · Publisher ↗
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...
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.
Correction: Anti-IL-5 Pathway Agents in Eosinophilic-Associated Disorders Across the Lifespan.
Lombardi C, Comberiati P, Ridolo E … +6 more , Cottini M, Yacoub MR, Casagrande S, Riccò M, Bottazzoli M, Berti A
Drugs · 2025 Apr · PMID 39985742 · Full text
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Revolutionary Changes in the Management of Lupus Nephritis: Towards De-Glucocorticoid or No-Glucocorticoid.
Tanaka Y
Drugs · 2025 Apr · PMID 39985741 · Publisher ↗
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 e...
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.
Safety and Longevity of Intraocular Pressure Control After Bimatoprost Implant Administration: Interim Analysis of a Phase 3b Clinical Trial (TRITON).
Silverstein SM, Oddone F, Kolko M … +13 more , Brinkmann CK, Christie WC, Bicket AK, Gous PNJ, Luebke J, Maram J, Nguyen A, Craven ER, Pu Y, Jiao J, Bejanian M, Robinson MR, TRITON Study Group
Drugs · 2025 Apr · PMID 39985740 · Full text
BACKGROUND: 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...
BACKGROUND: 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). PATIENTS AND METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRY: ClinicalTrials.gov identifier NCT03850782; registered 20 February 2019.
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