Gamifant (emapalumab-lzsg) / SOBI 
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  • ||||||||||  Gamifant (emapalumab) / SOBI
    Journal:  Emapalumab for the treatment of relapsed/refractory hemophagocytic lymphohistiocytosis. (Pubmed Central) -  Mar 2, 2020   
    Emapalumab is a fully human IgG1 monoclonal antibody directed against interferon-gamma (IFN-ᵯE;), which in November 2018 received the first global approval for the treatment of pediatric and adult patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent, or progressive disease or intolerance to HLH therapy. This review will highlight the pathophysiology of primary HLH, the therapeutic rationale for use of interferon-ᵯE; targeting therapy and potential limitations to its broader use in the treatment of HLH.
  • ||||||||||  Campath (alemtuzumab) / Sanofi, Jakafi oral (ruxolitinib) / Novartis, Incyte
    Clinical, Journal:  Adult haemophagocytic lymphohistiocytosis: a Review. (Pubmed Central) -  Jan 18, 2020   
    In adult HLH, infectious diseases, autoimmune disease and malignancy should be suspected so that disease-specific treatment can be given promptly. Treatment with corticosteroids combined or not with etoposide is the mainstay of treatment, but new therapies show promise of being effective.
  • ||||||||||  Soliris (eculizumab) / Alexion Pharma
    Thinking Beyond HLH: Clinical Features of Patients with Concurrent Presentation of Hemophagocytic Lymphohistiocytosis and Thrombotic Microangiopathy (World Center Marriott - Palms: Sabal) -  Dec 8, 2019 - Abstract #TCTASTCTCIBMTR2020TCT_586;    
    Conclusion Our observations suggest co-activation of both interferon and complement pathways as a potential culprit in the evolution of thrombotic microangiopathy in patients with inflammatory disorders like HLH and may offer novel therapeutic approaches for these critically ill patients. TMA should be considered in children with HLH and multi-organ failure, as early institution of a brief course of complement blocking therapy in addition to HLH targeted therapy may improve clinical outcomes in these patients (Figure 3).
  • ||||||||||  dexamethasone / Generic mfg., Jakafi oral (ruxolitinib) / Novartis, Incyte, Leustatin (cladribine) / J&J
    Dramatic Resolution of HLH after Treatment with the JAK 1/2 Inhibitor, Ruxolitinib (Hall B, Level 2 (Orange County Convention Center)) -  Nov 7, 2019 - Abstract #ASH2019ASH_3479;    
    The preclinical data by Albeituni et al. coupled with our clinical observations suggest that ruxolitinib may be a viable alternative to aggressive chemotherapy regimens such as HLH-94 or anti-IFN-γ (emapalumab-lzsg) therapy for HLH, and clinical trials should be considered.
  • ||||||||||  Gamifant (emapalumab) / SOBI
    Clinical, Journal:  Emapalumab: First Global Approval. (Pubmed Central) -  Sep 28, 2019   
    Emapalumab is under regulatory review in the EU for the treatment of primary HLH. This article summarizes the milestones in the development of emapalumab leading to this first global approval for HLH in the USA.
  • ||||||||||  Gamifant (emapalumab) / SOBI, etoposide IV / Generic Mfg.
    An Unprovoked Crisis: Hemophagocytic Lymphohistiocytosis (Exhibit Halls 3 and 4 (Street Level)) -  Aug 8, 2019 - Abstract #ACG2019ACG_1194;    
    There is no family history of HLH or any immune related disorders, and she had no past medical history. With that being said, an episode of HLH of unknown etiology seems to have been the cause of her symptoms.
  • ||||||||||  Neupogen (filgrastim) / Kyowa Hakko Kirin, Roche, Amgen
    Hemophagocytic Lymphohistiocytosis Disguised as Acute Liver Injury (Exhibit Halls 3 and 4 (Street Level)) -  Aug 8, 2019 - Abstract #ACG2019ACG_1137;    
    With worsening clinical pictures, emapalumab (Interferon gamma blocker) was started...The goal of therapy is to suppress hyper inflammation with agents such as corticosteroids, calcineurin inhibitors, and immunoglobulins. When a patient presents with prolonged fever and liver dysfunction of unknown etiology, HLH should be considered in the differential diagnosis as early recognition and treatment can prevent mortality, which can be high up to 75 % in the adult age group.
  • ||||||||||  Herceptin (trastuzumab) / Roche, Ultomiris IV (ravulizumab IV) / Alexion Pharma
    Journal:  Antibodies to watch in 2019. (Pubmed Central) -  Aug 1, 2019   
    In addition, our data show that 3 product candidates (leronlimab, brolucizumab, polatuzumab vedotin) may enter regulatory review by the end of 2018, and at least 12 (eptinezumab, teprotumumab, crizanlizumab, satralizumab, tanezumab, isatuximab, spartalizumab, MOR208, oportuzumab monatox, TSR-042, enfortumab vedotin, ublituximab) may enter regulatory review in 2019...Of these, 7 (tremelimumab, spartalizumab, BCD-100, omburtamab, mirvetuximab soravtansine, trastuzumab duocarmazine, and depatuxizumab mafodotin) are being evaluated in clinical studies with primary completion dates in late 2018 and in 2019, and are thus 'antibodies to watch'. We look forward to documenting progress made with these and other 'antibodies to watch' in the next installment of this article series.
  • ||||||||||  Gamifant (emapalumab-lzsg) / SOBI
    Enrollment open, Trial completion date, Trial initiation date, Trial primary completion date, HEOR:  Study to Assess the Efficacy and Safety of Emapalumab in Primary Haemophagocytic Lymphohistiocytosis (clinicaltrials.gov) -  Oct 24, 2018   
    P3,  N=34, Recruiting, 
    Trial completion date: Oct 2021 --> Oct 2022 | Trial primary completion date: Oct 2020 --> Oct 2021 Not yet recruiting --> Recruiting | Trial completion date: Jun 2020 --> Oct 2021 | Initiation date: Jan 2018 --> Oct 2018 | Trial primary completion date: Jun 2019 --> Oct 2020