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  • ||||||||||  Stivarga (regorafenib) / Bayer
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Metastases:  Study Of Intrabucally Administered Electromagnetic Fields and Regorafenib (clinicaltrials.gov) -  Sep 20, 2024   
    P2,  N=2, Terminated, 
    Recruiting --> Active, not recruiting N=25 --> 2 | Trial completion date: Nov 2025 --> May 2024 | Suspended --> Terminated | Trial primary completion date: May 2025 --> May 2024; Slow accruals
  • ||||||||||  botensilimab (AGEN1181) / Agenus, balstilimab (AGEN2034) / Agenus
    Trial initiation date:  BBOpCo: Botensilimab and Balstilimab Optimization in Colorectal Cancer (clinicaltrials.gov) -  Sep 20, 2024   
    P2,  N=15, Not yet recruiting, 
    Critically, this unique mechanism allows for vPD1/IL-12-mediated toxicities to be alleviated through the use of US Food and Drug Administration (FDA)-approved tumor necrosis factor (TNF) blockers such as etanercept. Initiation date: Jul 2024 --> Oct 2024
  • ||||||||||  Prolia (denosumab) / Amgen
    Review, Journal:  The use of denosumab in osteoporosis - an update on efficacy and drug safety. (Pubmed Central) -  Sep 20, 2024   
    Although bisphosphonates are often selected as initial therapy for osteoporosis, denosumab may be an appropriate initial therapy in patients at high risk for fracture, including older patients who have difficulty with the dosing requirements of oral bisphosphonates, as well as patients who are intolerant of, unresponsive to, or have contraindications to other therapies. Additional data is needed to address questions regarding treatment duration and discontinuation.
  • ||||||||||  Review, Journal:  B-cell Depletion Therapy in Pediatric Neuroinflammatory Disease. (Pubmed Central) -  Sep 20, 2024   
    B-cell depletion therapies can be safe and effective in pediatric patients. Anticipation and mitigation of common adverse effects through primary prevention strategies, close monitoring, and appropriate symptomatic management can improve safety and tolerability.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    Review, Journal:  A critical review of management of allogeneic transplant-eligible adults with Ph+ acute lymphoblastic leukaemia. (Pubmed Central) -  Sep 20, 2024   
    Can chemotherapy-free approaches, such as blinatumomab in conjunction with more potent TKIs, obviate the need for an allograft in high-risk patients?...Can salvage therapy and a subsequent allograft cure patients who relapse after not being transplanted in CR1? This manuscript reviews the latest data influencing contemporary management and discusses these controversies.
  • ||||||||||  Trial primary completion date:  Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response (clinicaltrials.gov) -  Sep 20, 2024   
    P3,  N=400, Recruiting, 
    This manuscript reviews the latest data influencing contemporary management and discusses these controversies. Trial primary completion date: Mar 2026 --> Mar 2027
  • ||||||||||  Granocyte (lenograstim) / Roche, Neupogen (filgrastim) / Kyowa Kirin, Amgen
    Enrollment closed, Enrollment change:  Continuous Versus Bolus Administration of G-CSF in Children With Cancer (clinicaltrials.gov) -  Sep 20, 2024   
    P4,  N=20, Active, not recruiting, 
    Trial primary completion date: Mar 2026 --> Mar 2027 Recruiting --> Active, not recruiting | N=40 --> 20
  • ||||||||||  Uplizna (inebilizumab-cdon) / Mitsubishi Tanabe, Amgen
    Enrollment open:  Inebilizumab in Acute Neuromyelitis Optica Spectrum Disorders (clinicaltrials.gov) -  Sep 20, 2024   
    P=N/A,  N=50, Recruiting, 
    ALC can serve as a predictor of palbociclib efficacy in patients with metastatic ER-positive, HER2-negative breast cancer. Not yet recruiting --> Recruiting
  • ||||||||||  HLX14 (denosumab biosimilar) / Fosun Pharma, Organon
    Trial completion, Trial primary completion date:  A Study to Evaluate the Efficacy and Safety of HLX14 vs. Denosumab Prolia (clinicaltrials.gov) -  Sep 20, 2024   
    P3,  N=514, Completed, 
    Not yet recruiting --> Recruiting Active, not recruiting --> Completed | Trial primary completion date: Apr 2024 --> Dec 2023
  • ||||||||||  Prolia (denosumab) / Amgen
    Journal, Surgery:  Post-craniopharyngioma surgery hypocalcemia due to denosumab use for osteoporosis: A case report. (Pubmed Central) -  Sep 20, 2024   
    More large RCTs are needed to verify these results. It underscores the necessity for clinicians to perform a thorough evaluation of the patient's overall health status, complete all requisite testing, pay particular attention to those in high-risk categories, and ensure serum calcium levels are monitored, along with conducting other essential tests, prior to and following each administration of denosumab.
  • ||||||||||  maridebart cafraglutide (AMG 133) / Amgen
    Trial completion:  A Study to Evaluate AMG 133 in Chinese Participants With Obesity or Overweight (clinicaltrials.gov) -  Sep 20, 2024   
    P1,  N=20, Completed, 
    It underscores the necessity for clinicians to perform a thorough evaluation of the patient's overall health status, complete all requisite testing, pay particular attention to those in high-risk categories, and ensure serum calcium levels are monitored, along with conducting other essential tests, prior to and following each administration of denosumab. Active, not recruiting --> Completed
  • ||||||||||  Xtandi (enzalutamide capsule) / Pfizer, Astellas, Prolia (denosumab) / Amgen, Pluvicto (lutetium Lu 177 vipivotide tetraxetan) / Novartis
    Clinical, Journal, Metastases:  Lu-177 PSMA vs Comparator Treatments and Survival in Metastatic Castration-Resistant Prostate Cancer. (Pubmed Central) -  Sep 20, 2024   
    Observed treatment effects on overall survival (OS) differed substantially in the first 2 randomized clinical trials of lutetium Lu 177 vipivotide tetraxetan (Lu-177) prostate-specific membrane antigen (PSMA) in metastatic castration-resistant prostate cancer...VISION randomized participants to receive treatment with or without Lu-177 PSMA in addition to physicians' choice of protocol-permitted treatments (PPT; approved hormonal treatments [such as abiraterone and enzalutamide], bisphosphonates, radiotherapy, denosumab, or glucocorticoids), excluding cabazitaxel...Findings of this secondary analysis of the TheraP and VISION randomized clinical trials suggest that the choice of comparator treatments (ie, cabazitaxel vs PPT) may explain the difference in the observed effect of Lu-177 PSMA on OS between the 2 trials. Causal inference methods such as RPSFTM and IPCW may help rule out crossover as a plausible explanation.
  • ||||||||||  Ibrance (palbociclib) / Pfizer, Xenical (orlistat) / Roche, GSK
    Journal, Adverse events:  Exploring the top 30 drugs associated with drug-induced constipation based on the FDA adverse event reporting system. (Pubmed Central) -  Sep 20, 2024   
    The drug with the highest ranking was lenalidomide (7,730 cases, 4.55%), with the most prevalent drug class being antineoplastic and immunomodulating agents...However, four drugs (orlistat, nintedanib, palbociclib, and dimethyl fumarate) presented an unexpected risk of constipation. Ranked by signal values, sevelamer carbonate emerged as the drug with the strongest risk signal [reporting odds ratio (95% CI): 115.51 (110.14, 121.15); PRR (?2): 83.78 (191,709.73); EBGM (EB05): 82.63 (79.4); IC (IC025): 6.37 (4.70)]...The median TTO for orlistat was 3
  • ||||||||||  zetomipzomib (KZR-616) / Kezar
    Trial completion date, Trial primary completion date:  A Study of Zetomipzomib (KZR-616) in Patients With Autoimmune Hepatitis (PORTOLA) (clinicaltrials.gov) -  Sep 19, 2024   
    P2,  N=24, Active, not recruiting, 
    Trial completion date: Aug 2024 --> Aug 2025 | Trial primary completion date: Aug 2024 --> Aug 2025 Trial completion date: Mar 2025 --> Aug 2025 | Trial primary completion date: Sep 2024 --> Feb 2025
  • ||||||||||  Trial completion date:  Application of N-of-1 Rheumatoid Arthritis (clinicaltrials.gov) -  Sep 19, 2024   
    P=N/A,  N=18, Not yet recruiting, 
    Trial completion date: Mar 2025 --> Aug 2025 | Trial primary completion date: Sep 2024 --> Feb 2025 Trial completion date: Jul 2025 --> Oct 2025