Prolia (denosumab) / Amgen 
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  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, imatinib / Generic mfg.
    Review, Journal:  Overview of « druggable » alterations by histological subtypes of sarcomas and connective tissue intermediate malignancies. (Pubmed Central) -  Jun 18, 2020   
    For each clinical setting, the level of evidence, the mechanism of action and the target are described. The two major axes include (i) identification of subgroups of tumors with druggable alteration irrespective of the histological diagnosis (e.g. NTRK), and (ii) druggable target of pathway related to the physiopathology of the tumor: denosumab and bone giant cell tumor, imatinib and soft tissue giant cell tumor, mTOR inhibitor and PECOMA.
  • ||||||||||  Prolia (denosumab) / Amgen
    Trial completion date, Trial primary completion date:  Denosumab Safety Assessment in Multiple Observational Databases (clinicaltrials.gov) -  Jun 17, 2020   
    P=N/A,  N=508215, Active, not recruiting, 
    The two major axes include (i) identification of subgroups of tumors with druggable alteration irrespective of the histological diagnosis (e.g. NTRK), and (ii) druggable target of pathway related to the physiopathology of the tumor: denosumab and bone giant cell tumor, imatinib and soft tissue giant cell tumor, mTOR inhibitor and PECOMA. Trial completion date: May 2020 --> Aug 2024 | Trial primary completion date: May 2020 --> Mar 2024
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Journal:  Denosumab cessation. (Pubmed Central) -  Jun 14, 2020   
    Trial completion date: May 2020 --> Aug 2024 | Trial primary completion date: May 2020 --> Mar 2024 No abstract available
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Review, Journal:  The RANKL-RANK Axis: A Bone to Thymus Round Trip. (Pubmed Central) -  Jun 12, 2020   
    In light of the RANKL-RANK multi-task function, an antibody targeting this pathway, denosumab, is now commonly used in the therapy of bone loss diseases including chronic inflammatory bone disorders and osteolytic bone metastases; furthermore, preclinical data support the therapeutic application of denosumab in the framework of a broader spectrum of tumors. Here, we discuss advances in cellular and molecular mechanisms elicited by RANKL-RANK pathway in the bone and thymus, and the extent to which its inhibition or augmentation can be translated in the clinical arena.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Clinical, Journal:  Evaluation of appropriate use of bisphosphonates and denosumab in patients with cancer. (Pubmed Central) -  Jun 12, 2020   
    Opportunities have been identified to optimize management of patients with cancer-related bone disease. Implementation of standardized tools may increase the rate of appropriate screening and initiation of bone-modifying therapy when warranted.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Journal:  Denosumab does not decrease the risk of lung metastases from bone giant cell tumour. (Pubmed Central) -  Jun 10, 2020   
    Denosumab does not decrease the risk of lung metastases in patients with bone GCT; the only important predictors for lung metastases in these patients are type of surgery and local recurrence. However, because the number of patients with lung metastases was small for a multivariate analysis, the possibility of denosumab's effect could not be completely eliminated.
  • ||||||||||  denosumab biosimilar / NeuClone, Serum Institute of India, NeuCeptin (trastuzumab biosimilar) / NeuClone, Serum Institute of India
    [VIRTUAL] NeuClone () -  Jun 9, 2020 - Abstract #BIO2020BIO_375;    
    NeuClone's pipeline consists of 20 biosimilars, six of which have been disclosed referencing Stelara (ustekinumab), Herceptin (trastuzumab), Perjeta (pertuzumab), Synagis (palivizumab), Prolia (denosumab) and Humira (adalimumab)...Additional biosimilars referencing Perjeta, Prolia, Synagis and more are undergoing manufacturing scale-up ahead of initiating clinical trials. NeuClone is exploring potential partnerships for biosimilar mAbs through clinical development and commercialisation into North America, Europe and other selected developed world and emerging markets.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Journal:  Denosumab in early-stage breast cancer - Authors' reply. (Pubmed Central) -  Jun 8, 2020   
    There is currently insufficient data to show that denosumab is not inferior to bisphosphonates in fracture prevention. No abstract available
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Journal:  Denosumab in early-stage breast cancer. (Pubmed Central) -  Jun 8, 2020   
    No abstract available No abstract available
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Journal:  Denosumab in early-stage breast cancer. (Pubmed Central) -  Jun 8, 2020   
    No abstract available No abstract available
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Review, Journal:  RANKL is a therapeutic target of bone destruction in rheumatoid arthritis. (Pubmed Central) -  Jun 8, 2020   
    Denosumab, a human antibody against receptor activator of nuclear factor-kappa B ligand (RANKL), efficiently suppressed the progression of bone erosion in patients with RA by suppressing osteoclast differentiation and activation in several clinical studies, although it had no effect on inflammation or cartilage destruction. Denosumab, in combination with anti-rheumatic drugs, is considered a pivotal therapeutic option for the prevention of bone destruction in RA.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Clinical, Journal:  Comparison of Teriparatide and Denosumab in Patients Switching from Long-Term Bisphosphonate Use. (Pubmed Central) -  Jun 8, 2020   
    Denosumab, in combination with anti-rheumatic drugs, is considered a pivotal therapeutic option for the prevention of bone destruction in RA. Among patients who use long-term bisphosphonates, the decision of switching to teriparatide should be made with caution, especially for patients at high risk of hip fracture.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Review, Journal:  Pros and Cons of Denosumab Treatment for Osteoporosis and Implication for RANKL Aptamer Therapy. (Pubmed Central) -  Jun 3, 2020   
    With extra advantages such as high stability, low immunogenicity and easy production over antibodies, aptamers are hypothesized to be promising candidates for therapeutic drugs targeting RANKL to counteract osteoporosis. In this review, we focus on the pros and cons of denosumab treatment in osteoporosis and the implication for novel aptamer treatment.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Journal:  Brown tumor of the iliac crest initially misdiagnosed as a giant cell tumor of the bone. (Pubmed Central) -  Jun 3, 2020   
    The patient was scheduled for surgical curettage, with a course of neoadjuvant denosumab...One of the best ways to distinguish these two diagnoses appears to be through biochemical workup. Differentiating brown tumors from giant cell tumors and aneurysmal bone cysts is crucial in order to ensure better patient care and prevent unnecessary morbid surgical interventions.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Clinical, Journal:  Denosumab in Patients with Fibrous Dysplasia Previously Treated with Bisphosphonates. (Pubmed Central) -  May 29, 2020   
    Our results indicate that denosumab 60 mg 3-monthly is a promising, well-tolerated treatment for most patients with FD/MAS refractory to bisphosphonate therapy. These results together with those of previously published case reports provide the necessary background for the design of a larger, controlled study.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Journal:  Activation of RANK/RANKL/OPG Pathway Is Involved in the Pathophysiology of Fibrous Dysplasia and Associated With Disease Burden. (Pubmed Central) -  May 29, 2020   
    These results together with those of previously published case reports provide the necessary background for the design of a larger, controlled study. Animal models show local expression of RANKL in bone lesions, and treatment with the RANKL neutralizing antibody denosumab decreased lesion expansion rate in a patient with aggressive FD...These data are consistent with the role of RANKL as a driver in FD-induced osteoclastogenesis.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, zoledronic acid / Generic mfg.
    Journal:  Current concepts in the treatment of giant cell tumour of bone. (Pubmed Central) -  May 27, 2020   
    Reduced dose intensity is being studied to reduce long term side-effects. Further research on bisphosphonates and other targets including H3.3-G34W remains warranted.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Journal:  Further Nonvertebral Fracture Reduction Beyond 3 Years for up to 10 Years of Denosumab Treatment. (Pubmed Central) -  May 26, 2020   
    P3
    The use of denosumab could be a good therapeutic option without causing severe adverse effects in recipients of haematopoietic transplantation. Long-term denosumab treatment, beyond 3 and up to 10 years, was associated with further reductions in NVF rates vs the first 3 years.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Clinical, Journal:  Successful Treatment of Tuberculosis-Associated Hypercalcemia with Denosumab in a Patient with Acute Kidney Injury. (Pubmed Central) -  May 23, 2020   
    Other indications include bone loss in patient with prostate or breast cancer undergoing ablation therapy, hypercalcemia from malignancy and more recently it was approved for glucocorticoid-induced osteoporosis (1, 2). To our knowledge, we present the first case of successful treatment of tuberculosis (TB)-associated hypercalcemia with denosumab.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Clinical, Journal:  Idiopathic bone marrow oedema: Outcome of 3 cases treated with denosumab (Pubmed Central) -  May 23, 2020   
    Outcome was favourable with clinical and bone oedema resolution, with no notable complications. This report demonstrates that denosumab is a treatment option for the clinical/radiological resolution of bone marrow oedema and seems to shorten the clinical course of the process.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Clinical, Journal:  Clinical benefits of bone targeted agents in early breast cancer. (Pubmed Central) -  May 23, 2020   
    Efforts are ongoing to try to understand the biologic implications of these results. For now, the use of denosumab in early cancers is limited to its use for fracture prevention using the 60mg every 6 months dosing schedule.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, zoledronic acid / Generic mfg.
    [VIRTUAL] BONE METABOLISM ASSESSMENT IN PATIENTS WITH RECENT DIAGNOSIS OF GIANT CELL ARTERITIS () -  May 22, 2020 - Abstract #EULAR2020EULAR_4229;    
    Low bone mass and vitamin D insufficiency are frequent in patients with recent diagnoses of GCA and up to 38% have poor bone microarchitecture at baseline. Thus, it’s important to perform a bone mass assessment in all patients with recent diagnose of ACG and initiate therapeutic or preventive anti-OP treatment if required.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    [VIRTUAL] MULTIPLE REBOUND-ASSOCIATED VERTEBRAL FRACTURES AFTER DENOSUMAB DISCONTINUATION IN RHEUMATOLOGY CLINIC (Poster View) -  May 22, 2020 - Abstract #EULAR2020EULAR_4174;    
    Most cases are associated with long-term (>2 years) denosumab administration without previous treatment with bisphosphonates. Rheumatologists should be alert of this complication since the reported compliance in patients under denosumab treatment is only 46% (1) and the expected incidence of RAVFs after denosumab discontinuation has been reported to be 10% (2).
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    [VIRTUAL] ANTI RANK LIGAND IN ACUTE CHARCOT NEURO-OSTEOATHROPATHY OF THE FOOT: A PROMISING TREATMENT () -  May 22, 2020 - Abstract #EULAR2020EULAR_3595;    
    One to three injection of denosumab 60 mg was efficient in preventing flare and further bone destruction in a 16 months medium follow up. These results justify the conduction of a randomized control study to assess the efficacy of denosumab as the first-line pharmacological therapy in acute CN.