- |||||||||| Prolia (denosumab) / Amgen
Embolization of huge giant cell tumor () - Apr 10, 2024 - Abstract #ECIO2024ECIO_479;
However, the drug caused mandibular osteonecrosis, necessitating treatment withdrawal. Due to the location, size, and marked vascularity, embolization was chosen as therapeutic option.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
Review, Journal, IO biomarker: A review of immunotargeted therapy for Philadelphia chromosome positive acute lymphoblastic leukaemia: making progress in chemotherapy-free regimens. (Pubmed Central) - Apr 10, 2024
Since 2000, targeted therapy combined with chemotherapy, represented by the tyrosine kinase inhibitor Imatinib, has become the first-line treatment for PH?+?ALL...More recently, some innovative immune-targeted therapy greatly improved the prognosis of PH?+?ALL, such as Blinatumomab and Inotuzumab Ozogamicin...These new therapeutic interventions are changing the treatment landscape for PH?+?ALL. In summary, this review discusses the current advancements in targeted therapeutic agents shift in the treatment strategy of PH?+?ALL towards using more tolerable chemotherapy-free induction and consolidation regimens confers better disease outcomes and might obviate the need for HSCT.
- |||||||||| Ibrance (palbociclib) / Pfizer, Keytruda (pembrolizumab) / Merck (MSD)
Enrollment open, Trial completion date, Trial primary completion date: Pembrolizumab, Endocrine Therapy, and Palbociclib in Treating Postmenopausal Patients With Newly Diagnosed Metastatic Stage IV Estrogen Receptor Positive Breast Cancer (clinicaltrials.gov) - Apr 10, 2024
P2, N=47, Recruiting,
In summary, this review discusses the current advancements in targeted therapeutic agents shift in the treatment strategy of PH?+?ALL towards using more tolerable chemotherapy-free induction and consolidation regimens confers better disease outcomes and might obviate the need for HSCT. Active, not recruiting --> Recruiting | Trial completion date: Mar 2024 --> Dec 2024 | Trial primary completion date: Mar 2024 --> Dec 2024
- |||||||||| Opdivo (nivolumab) / BMS
Enrollment change, Trial completion date, Trial primary completion date: CA209-8TT: Pan Tumor Rollover Study (clinicaltrials.gov) - Apr 10, 2024
P2, N=1500, Recruiting,
Active, not recruiting --> Recruiting | Trial completion date: Mar 2024 --> Dec 2024 | Trial primary completion date: Mar 2024 --> Dec 2024 N=800 --> 1500 | Trial completion date: Aug 2025 --> Aug 2029 | Trial primary completion date: Aug 2025 --> Aug 2029
- |||||||||| Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi
Trial completion date, Trial primary completion date: Stem Cell Transplantation in Crohn's Disease (clinicaltrials.gov) - Apr 10, 2024
P1/2, N=15, Recruiting,
N=800 --> 1500 | Trial completion date: Aug 2025 --> Aug 2029 | Trial primary completion date: Aug 2025 --> Aug 2029 Trial completion date: Jan 2024 --> Jan 2025 | Trial primary completion date: Jan 2024 --> Jan 2025
- |||||||||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Enrollment closed, Trial completion date, Trial primary completion date: Romosozumab to Improve Bone Mineral Density and Architecture in Chronic SCI (clinicaltrials.gov) - Apr 9, 2024
P2, N=36, Active, not recruiting,
Trial completion date: Jan 2024 --> Jan 2025 | Trial primary completion date: Jan 2024 --> Jan 2025 Recruiting --> Active, not recruiting | Trial completion date: Aug 2024 --> Mar 2027 | Trial primary completion date: Feb 2024 --> Feb 2026
- |||||||||| Oncorine (recombinant human adenovirus type 5) / Mergen Ltd.
Review, Journal, Oncolytic virus: New hopes for the breast cancer treatment: perspectives on the oncolytic virus therapy. (Pubmed Central) - Apr 9, 2024
Oncolytic virus therapy holds substantial potential in breast cancer treatment, demonstrating safety in trials. Multi-approach strategies combining OVs with conventional therapies exhibit more promising therapeutic effects than monotherapy, signalling a hopeful future for OV-based breast cancer treatments.
- |||||||||| Rinvoq (upadacitinib) / AbbVie, Enbrel (etanercept) / Pfizer, Amgen, Humira (adalimumab) / AbbVie
Health system specialty pharmacy: Ensuring continuity of care during provider transitions () - Apr 9, 2024 - Abstract #AMCP2024AMCP_154;
HSSP teams successfully provided conti- nuity of care during a transitional period for patients with rheumatologic conditions. Because of their high-touch care, patients were not lost to follow-up and did not report increased symptoms during this period.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen, Actemra IV (tocilizumab) / Roche, JW Pharma
Identification of high-grade cytokine release syndrome in retrospective databases () - Apr 9, 2024 - Abstract #AMCP2024AMCP_65;
The model performed moderately well in hospital chargemaster and EHR data. These indicators can inform CRS severity in RW data, which is critical for treatment decision-making, espe- cially given the high proportion of patients with codes for unspecified CRS grade.
- |||||||||| Ibrance (palbociclib) / Pfizer, Imbruvica (ibrutinib) / AbbVie, J&J
The real-world value of medically integrated dispensing () - Apr 9, 2024 - Abstract #AMCP2024AMCP_42;
This finding held in the sensitivity analysis with follow-up periods of 6 and 12 months. Although this result suggests benefits of MID in oncology, larger studies with more sites, more drugs, and additional metrics are needed.
- |||||||||| oxaliplatin / Generic mfg., irinotecan / Generic mfg.
Adverse event costs associated with systemic therapies for metastatic colorectal cancer previously treated with oxaliplatin- and irinotecan- based chemotherapy therapy in the United States () - Apr 9, 2024 - Abstract #AMCP2024AMCP_30;
BACKGROUND: Systemic therapies such as fruquintinib, regorafenib, and trifluridine/tipiracil (T/T) have demon- strated survival benefits vs best supportive care (BSC) in patients with metastatic colorectal cancer (mCRC) pre- viously treated with oxaliplatin- and irinotecan-based chemotherapy (OIC)...OBJECTIVE: To compare the AE management costs of fruquin- tinib, regorafenib, T/T and T/T+bevacizumab (T/T+bev) for mCRC previously treated with OIC, from US Commercial and Medicare payer perspectives... Based on the cost-consequence model results, fruquintinib was associated with lower AE manage- ment costs compared with regorafenib, T/T, and T/T+bev for patients with mCRC previously treated with OIC, which should be considered in treatment and formulary decision- making.
- |||||||||| Review, Journal: Novel and Emerging LDL-C Lowering Strategies: A New Era of Dyslipidemia Management. (Pubmed Central) - Apr 9, 2024
Molecular insights into alternative pathways have spurred the investigation of emerging agents, offering promising perspectives for novel medications with efficacy comparable to established treatments, associated with advantages in cost and administration. This review provides a comprehensive overview of the evolving landscape of lipid-lowering strategies, highlighting the progress made in addressing ASCVD risk and the potential of upcoming therapies to further optimize cardiovascular prevention.
- |||||||||| Review, Journal: Interplay of cytokines in the pathophysiology of atopic dermatitis: insights from Murin models and human. (Pubmed Central) - Apr 9, 2024
In addition, clinical trials with fezakinumab, targeting IL-22, have demonstrated promising results, particularly in severe AD cases...Similarly, thymic stromal lymphopoietin (TSLP), integral to type 2 immune responses, induces dermatitis in animal models and is elevated in human AD, yet clinical treatments like tezepelumab exhibit limited efficacy...Consequently, this review delineates the distinct roles of cytokines in the pathogenesis of AD, juxtaposing their significance in human AD from clinical trials against insights gleaned from AD mouse models. This approach will improve our understanding of interspecies variation and facilitate a deeper insight into the pathogenesis of AD in humans.
- |||||||||| ivabradine / Generic mfg.
Trial completion date, Trial primary completion date: RECOVER-AUTONOMIC: Platform Protocol, Appendix B (Ivabradine) (clinicaltrials.gov) - Apr 9, 2024
P2, N=180, Enrolling by invitation,
N=47 --> 0 | Not yet recruiting --> Withdrawn Trial completion date: Sep 2025 --> Mar 2026 | Trial primary completion date: Jun 2025 --> Dec 2025
- |||||||||| AVT03 (denosumab biosimilar) / Alvotech, Dr. Reddy's
Trial completion: AVT03 With Prolia in Healthy Male Subjects (clinicaltrials.gov) - Apr 8, 2024
P1, N=209, Completed,
Trial completion date: Sep 2025 --> Mar 2026 | Trial primary completion date: Jun 2025 --> Dec 2025 Active, not recruiting --> Completed
- |||||||||| Review, Journal: Immune Therapies of B-cell Acute Lymphoblastic Leukaemia in Children and Adults. (Pubmed Central) - Apr 8, 2024
We review data on US Food and Drug Administration (FDA)-approved immune therapies for B-cell ALL in children and adults including blinatumomab, inotuzumab ozogamicin, tisagenlecleucel, and brexucabtagene autoleucel. We also summarize pharmaco-dynamics, pharmaco-kinetics, and pharmaco-economics of these interventions.
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono, Vectibix (panitumumab) / Amgen
Review, Journal, Metastases: Current advances in targeted therapy for metastatic colorectal cancer - Clinical translation and future directions. (Pubmed Central) - Apr 8, 2024
The non-invasive monitoring of molecular resistance to targeted therapies using Next Generation Sequencing analysis of circulating tumor-derived DNA (ctDNA) and captured sequencing of tumors have improved patient selection for targeted therapies. This review will focus on how latest advances, challenges and future directions in the development of targeted therapies in mCRC.
- |||||||||| Repatha (evolocumab) / Amgen, Astellas
Enrollment change, Trial termination: FOURIER LEGACY: Observational Study of Cardiovascular Disease. (clinicaltrials.gov) - Apr 7, 2024
P=N/A, N=1137, Terminated,
This review will focus on how latest advances, challenges and future directions in the development of targeted therapies in mCRC. N=10000 --> 1137 | Recruiting --> Terminated; Withdrawal of funding.
- |||||||||| Aranesp (darbepoetin alfa) / Amgen, Kyowa Kirin, Ilaris (canakinumab) / Novartis
Trial completion date, Trial primary completion date: Canakinumab With Darbepoetin Alfa in PTs With Lower-Risk MDS Who Have Failed ESA (clinicaltrials.gov) - Apr 7, 2024
P1/2, N=41, Recruiting,
N=10000 --> 1137 | Recruiting --> Terminated; Withdrawal of funding. Trial completion date: Feb 2024 --> Jun 2024 | Trial primary completion date: Feb 2024 --> Jun 2024
- |||||||||| Journal: Preventive Treatment of Migraine. (Pubmed Central) - Apr 7, 2024
Six drugs targeting CGRP (four monoclonal antibodies and two gepants) are now available for the preventive treatment of episodic migraine in adults. The efficacy of CGRP-targeted medications in the acute and preventive treatment of migraine, together with good safety and tolerability, has led to the emergence of new approaches to preventive treatment.
- |||||||||| Prolia (denosumab) / Amgen, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Journal: The Dutch multidisciplinary guideline osteoporosis and fracture prevention, taking a local guideline to the international arena. (Pubmed Central) - Apr 6, 2024
In our new multidisciplinary guideline osteoporosis and fracture prevention, we developed 5 "relatively new statements" that are all a crucial step forward in the optimization of diagnosis and treatment for fracture prevention. We also developed 5 flowcharts, and we suppose that this may be helpful for individual doctors and their patients in daily practice and may facilitate implementation.
- |||||||||| briquilimab (JSP191) / Jasper Therap
Briquilimab, an Anti-Human CD117 Antibody, Effectively Treats Epicutaneous Allergen-Induced Atopic Dermatitis in Mouse Model Expressing Chimeric Human/Mouse CD117 (Bilbao) - Apr 5, 2024 - Abstract #EAACI2024EAACI_1053;
Importantly, therapeutic treatment with briquilimab on day 21 in HDM/SEB hmCD117 mice, after AD was established, also led to improved skin ES by 85%, SS by 80%, and HS by 95% on day 37, accompanied by a 70% decrease in dermal mast cells and a 90% reduction in dermal inflammatory leukocytes (P<0.05 for all measures), indicating that briquilimab can reverse AD pathology. Conclusion This study provides early evidence that briquilimab may be a novel therapeutic agent for AD.
- |||||||||| briquilimab (JSP191) / Jasper Therap
The BEACON Study: A Phase 1b/2a, Dose Escalation Study of Safety, Pharmacokinetic/Pharmacodynamic and Preliminary Clinical Activity of the c-Kit Mab Briquilimab in Adults with symptomatic Chronic Spontaneous Urticaria (CSU) (Granada) - Apr 5, 2024 - Abstract #EAACI2024EAACI_680;
The trial will enroll approximately 40 patients from US and Germany. Results Safety and tolerability: Review of laboratory date (hematology, clinical chemistry, urinalysis), physical examinations, vital signs, ECG, reports of treatment emergent adverse events (TEAEs) Pharmacokinetics: Cmax, tmax and AUClast Preliminary Efficacy: Change from baseline to Week 12 in Urticaria Activity Score (UAS7), Hives Severity Score (HSS7), Itch Severity Score (ISS7) and Urticaria Control Test (UCT) Pharmacodynamics: Serum tryptase, anti-drug antibody assessments Conclusion his controlled multi-ascending dose trial will provide important assessments into the safety, tolerability and initial evidence of efficacy in patients administered briquilimab with treatment-refractory CSU and inform potential future clinical trials on optimal dosing and dosing schedules.
- |||||||||| Enbrel (etanercept) / Pfizer, Amgen
Journal: Etanercept-synthesizing adipose-derived stem cell secretome: A promising therapeutic option for inflammatory bowel disease. (Pubmed Central) - Apr 5, 2024
These results support the benefits of tezepelumab use in patients with severe, uncontrolled asthma, particularly in patients for whom respiratory illnesses are a prominent asthma exacerbation trigger. These results suggest that the secretome derived from ASCs that synthesize etanercept has potential as a therapeutic agent for the treatment of IBD, potentially enhancing treatment efficacy by merging the anti-inflammatory qualities of the ASC secretome with etanercept's targeted approach to better address the multifaceted pathophysiology of IBD.
- |||||||||| Kepivance (palifermin) / SOBI, Amgen, Neupogen (filgrastim) / Kyowa Kirin, Amgen
Enrollment open: Base Editing for Mutation Repair in Hematopoietic Stem & Progenitor Cells for X-Linked Chronic Granulomatous Disease (clinicaltrials.gov) - Apr 5, 2024
P1/2, N=10, Enrolling by invitation,
These results suggest that the secretome derived from ASCs that synthesize etanercept has potential as a therapeutic agent for the treatment of IBD, potentially enhancing treatment efficacy by merging the anti-inflammatory qualities of the ASC secretome with etanercept's targeted approach to better address the multifaceted pathophysiology of IBD. Not yet recruiting --> Enrolling by invitation
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