Prolia (denosumab) / Amgen 
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  • ||||||||||  Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
    Clinical, Journal:  Bisphosphonate and denosumab initiation in older adults in Ontario, Canada: a population-based cohort study. (Pubmed Central) -  Nov 3, 2020   
    The clinical characteristics and monitoring of new users of bisphosphonates and denosumab generally align with practice guidelines, product monographs, and drug reimbursement criteria. Given differences between real-world users and RCT participants, there may be a role for safety and effectiveness studies of bisphosphonates and denosumab in routine care.
  • ||||||||||  [VIRTUAL] Reproducible, MoA-reflecting Reporter-based Bioassays to Enable Drug Development of Biosimilars and Biobetters (virtual poster hall) -  Nov 3, 2020 - Abstract #SITC2020SITC_2071;    
    Importantly, these bioassays have been optimized in a thaw-and-use cell format, which eliminates the need for cell culture and ensures high reproducibility, convenience and transferability. Conclusions In summary, bioluminescent reporter-based bioassays offer significant advantages over primary cell-based bioassays and are valuable tools for the development and manufacturing of novel biologics targeting cytokine and growth factor pathways.
  • ||||||||||  [VIRTUAL] Reproducible, MoA-reflecting Reporter-based Bioassays to Enable Drug Development of Biosimilars and Biobetters (virtual poster hall) -  Nov 3, 2020 - Abstract #SITC2020SITC_2003;    
    Importantly, these bioassays have been optimized in a thaw-and-use cell format, which eliminates the need for cell culture and ensures high reproducibility, convenience and transferability. Conclusions In summary, bioluminescent reporter-based bioassays offer significant advantages over primary cell-based bioassays and are valuable tools for the development and manufacturing of novel biologics targeting cytokine and growth factor pathways.
  • ||||||||||  Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
    Clinical, Journal:  Primary bone adult T cell lymphoma with multiple skeletal lesions and debilitating painful osteolysis: a case report. (Pubmed Central) -  Nov 2, 2020   
    The subsequent two courses of chemotherapy in addition to denosumab resulted in an objective partial metabolic response indicated in 18-fluorine-fluorodeoxyglucose positron emission tomography/computed tomography (18F-FDG PET/CT). Although very rare, the bone involvement of ATL could be used for the differential diagnosis for local osteolytic bone pain in addition to multiple myeloma and metastatic bone diseases.
  • ||||||||||  Journal:  Pharmacotherapy in Rare Skeletal Diseases. (Pubmed Central) -  Nov 2, 2020   
    Additionally, there are different phase 3 trials ongoing assessing the efficacy and safety of drugs for osteogenesis imperfecta, achondroplasia, and fibrodysplasia ossificans progressiva (denosumab, vosoritide, palovarotene).Because all these diseases are rare, the number of investigated patients in the trials is small, and the knowledge about rare side effects and long-term outcome is limited. Therefore it is recommended to treat the patients in specialized centers where the effects of the drugs can be evaluated and data about safety, side effects, and efficacy can be collected.Based on the fact that most drugs for rare diseases are highly expensive clear indications for start of a treatment, evaluation of the therapy and recommendations how long a treatment has to be administrated are urgently needed.
  • ||||||||||  Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
    Review, Journal:  Osteoporosis: A Long-Term and Late-Effect of Breast Cancer Treatments. (Pubmed Central) -  Nov 1, 2020   
    However, only certain women will lose bone of sufficient magnitude to merit treatment with anti-osteoporosis drugs. The narrative review is intended for medical, surgical, radiation oncologists, and other mid-level providers, and provides an overview of bone loss and the prevention and treatment of osteoporosis.
  • ||||||||||  Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
    Review, Journal:  Denosumab in Giant Cell Tumor of Bone: Current Status and Pitfalls. (Pubmed Central) -  Nov 1, 2020   
    The optimal duration, long term safety, maintenance dose, and optimum indications remain to be elucidated. With these concerns in mind, this review warns that the denosumab therapy of GCTB should be applied with caution.
  • ||||||||||  Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
    Journal:  Medical students' knowledge of Medication Related Osteonecrosis of the Jaw. (Pubmed Central) -  Oct 30, 2020   
    A better level of knowledge and awareness by medical doctors and young physicians may lead, in future, to minimize incidence of MRONJ as well as to a better resolution of ONJ cases. Theoretical and practical initiatives could be promoted to improve and consolidate the knowledge of future physicians about this important issue.
  • ||||||||||  Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo, Evenity (romosozumab) / Astellas, Amgen, UCB
    Journal:  Which Drug Next? Sequential Therapy for Osteoporosis. (Pubmed Central) -  Oct 30, 2020   
    The article by Kendler et al. in this issue of JCEM reports alendronate preserves bone accrued during administration of denosumab.
  • ||||||||||  Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
    Clinical, Journal:  Are women with osteoporosis treated with denosumab at risk of severe COVID-19? (Pubmed Central) -  Oct 30, 2020   
    While bone-modifying agents such as bisphosphonates and denosumab are crucial to preventing skeletal-related events in patients with bone metastases, the optimal duration remains undefined...No abstract available No abstract available
  • ||||||||||  Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
    Journal:  Giant cell tumors of the sacrum: is non-operative treatment effective? (Pubmed Central) -  Oct 30, 2020   
    No abstract available This study offers a non-surgical management option that provides good mid-term local control while preserving neurological function in these complex lesions.
  • ||||||||||  Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
    Journal:  Denosumab for management of severe hypercalcemia in primary hyperparathyroidism. (Pubmed Central) -  Oct 29, 2020   
    After that, seven patients underwent successful parathyroidectomy and achieved eucalcemia or hypocalcemia, one patient developed the recurrence of parathyroid cancer after initial surgery, while two patients with severe cardiovascular pathology refused surgery. Our study shows that denosumab is a useful tool in PHPT-associated hypercalcemia before surgery or if surgery is contraindicated.
  • ||||||||||  Prolia (denosumab) / Amgen, Opdivo (nivolumab) / BMS
    Trial completion date, Trial primary completion date, PD(L)-1 Biomarker, IO biomarker:  Denosumab and Nivolumab Combination as 2d-line Therapy in Stage IV NSC Lung Cancer With Bone Metastases (DENIVOS) (clinicaltrials.gov) -  Oct 28, 2020   
    P2,  N=86, Recruiting, 
    Our study shows that denosumab is a useful tool in PHPT-associated hypercalcemia before surgery or if surgery is contraindicated. Trial completion date: Dec 2023 --> Jul 2023 | Trial primary completion date: Sep 2022 --> Jul 2021
  • ||||||||||  Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
    Clinical, Journal, Real-World Evidence:  Treatment Effects of Bisphosphonates and Denosumab on Survival and Refracture from Real-World Data of Hip-Fractured Patients. (Pubmed Central) -  Oct 28, 2020   
    Higher risk of a subsequent HF was observed in women on DMAB (SHR 1.77, 95% CI 1.08-2.91) and on iBP (SHR 1.81, 95% CI 1.35-2.41), and in men on oBPs (SHR 2.89, 95% CI 1.58-5.30). Patients who were treated with antiresorptive medications after HF had longer survival than patients without treatment, highlighting the importance of initiation of antiresorptive treatment after HF.
  • ||||||||||  Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
    Retrospective data, Journal:  Bone complications in patients with multiple myeloma in five European countries: a retrospective patient chart review. (Pubmed Central) -  Oct 27, 2020   
    They are frequently associated with hospitalization and analgesic use. Data from this study, conducted in the era of novel anti-myeloma therapies and before the approval of denosumab for use in patients with MM, suggest that although most patients (75%) received bisphosphonates, use of anti-resorptive therapy for prevention of bone complications may be suboptimal in patients with NDMM, irrespective of renal function.
  • ||||||||||  Tymlos (abaloparatide) / Radius, Teijin, Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo, recombinant parathyroid hormone (PTH-1-34) / Emisphere Technologies, Novartis
    Review, Journal:  Abaloparatide and the Spine: A Narrative Review. (Pubmed Central) -  Oct 24, 2020   
    However, abaloparatide (synthetic parathyroid-related peptide (PTHrP), Tymlos, Radius Health, Waltham, MA), the second drug in this family, has recently become available for use. In this narrative review, we review the mechanism, effects, and benefits of abaloparatide compared to alternative treatments as well as discuss the current literature in regard to its effect on osteoporosis-related complications in the spine.
  • ||||||||||  Prolia (denosumab) / Amgen
    Trial completion, Trial completion date:  Denosumab In Addition To Intense Urate-Lowering Therapy for Bone Erosions (clinicaltrials.gov) -  Oct 21, 2020   
    P2,  N=20, Completed, 
    Trial completion date: Aug 2020 --> Nov 2022 Recruiting --> Completed | Trial completion date: Mar 2021 --> Mar 2020
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Clinical, Journal:  HTLV-1 viral oncogene HBZ drives bone destruction in adult T cell leukemia. (Pubmed Central) -  Oct 16, 2020   
    Using patient-derived xenografts from primary human ATL cells to induce lymphoproliferative disease, we also observed profound tumor-induced bone destruction and increased c-Fos and RANKL gene expression. Together, these data show the critical role of HBZ in driving ATL-associated bone loss through RANKL and identify denosumab as a potential treatment to prevent bone complications in ATL patients.
  • ||||||||||  Prolia (denosumab) / Amgen
    New P4 trial:  Study of XGEVA (clinicaltrials.gov) -  Oct 14, 2020   
    P4,  N=35, Not yet recruiting, 
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    [VIRTUAL] Recurrent Metastatic Giant Cell Tumor in the Lung With Denosumab-Treatment Effect () -  Oct 13, 2020 - Abstract #CAP2020CAP_415;    
    Currently, data on denosumab following curettage and rates of recurrent lung metastasis are limited. Our case demonstrates diagnostic challenges in meta-static GCT treated with a RANK-L–inhibitor and highlights the need for investigation of recurrent lung metastasis in adjuvant denosumab treatment in GCT.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    [VIRTUAL] HYPERCALCEMIC CRISIS IN SARCOIDOSIS () -  Oct 12, 2020 - Abstract #CHEST2020CHEST_2371;    
    Hypercalcemic crisis is a rare presentation for sarcoidosis. This case demonstrates the difficulty in the diagnosis of and the importance of early recognition of sarcoidosis from often subtle findings in the outpatient setting.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    [VIRTUAL] TRIPLE SYNCHRONOUS PRIMARY LUNG AND ESOPHAGEAL TUMORS IN AN ADULT: A RARE AND NOVEL OCCURRENCE () -  Oct 12, 2020 - Abstract #CHEST2020CHEST_2022;    
    To the best of our knowledge, this is the first reported case of synchronous unrelated coinciding triple primary tumors, including pulmonary mucinous adenocarcinoma, esophageal adenocarcinoma, and pulmonary schwannoma in a single patient. Further research is needed to define the true extent of this ailment in order to learn more about the clinical characteristics and patient-specific risk factors, which will ultimately enhance early detection and prognosis.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Tecentriq (atezolizumab) / Roche
    [VIRTUAL] A RARE OCULAR CLUE TO DIAGNOSIS OF AN EXTENSIVE SMALL CELL LUNG CANCER: DIAGNOSTIC AND THERAPEUTIC IMPLICATIONS () -  Oct 12, 2020 - Abstract #CHEST2020CHEST_1996;    
    Metastases to the eye are relatively rare due to the absence of a lymphatic system. Because of the rarity of an iris nodule as a presenting symptom for SCLC, the aggressiveness of the primary cancer, and the implications for treatment, the importance of recognizing and investigating anterior uveal tumors as likely metastatic disease cannot be understated.
  • ||||||||||  Leustatin (cladribine) / J&J
    [VIRTUAL] PULMONARY LANGERHANS CELL HISTIOCYTOSIS: A RARE OCCURRENCE IN A NON-SMOKING ELDERLY WOMAN () -  Oct 12, 2020 - Abstract #CHEST2020CHEST_1659;    
    Therapy was supported with granulocyte-colony stimulating factor (G-CSF), an erythropoietin-stimulating agent (ESA), and denosumab. The optimal treatment for PLCH is still not well understood but overall survival is good with a five-year survival of more than 75% reported in most studies.
  • ||||||||||  CMAB807 (denosumab biosimilar) / 3SBio
    Trial completion:  Phase 1 Study to Compare CMAB807 Injection to Prolia (clinicaltrials.gov) -  Oct 12, 2020   
    P1,  N=132, Completed, 
    The optimal treatment for PLCH is still not well understood but overall survival is good with a five-year survival of more than 75% reported in most studies. Active, not recruiting --> Completed