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  • ||||||||||  Stivarga (regorafenib) / Bayer
    Trial completion date, Trial primary completion date, Metastases:  Study Of Intrabucally Administered Electromagnetic Fields and Regorafenib (clinicaltrials.gov) -  Dec 5, 2023   
    P2,  N=25, Suspended, 
    Trial completion date: Mar 2024 --> Mar 2025 | Trial primary completion date: Mar 2024 --> Mar 2025 Trial completion date: Mar 2024 --> Jul 2024 | Trial primary completion date: Nov 2023 --> Apr 2024
  • ||||||||||  zeluvalimab (AMG 404) / Amgen
    Trial completion, Metastases:  AMG 404 in Patients With Advanced Solid Tumors (clinicaltrials.gov) -  Dec 5, 2023   
    P1,  N=171, Completed, 
    Not yet recruiting --> Recruiting Active, not recruiting --> Completed
  • ||||||||||  Aphexda (motixafortide) / BioLineRx, Gloria Pharma
    Review, Journal:  Motixafortide: First Approval. (Pubmed Central) -  Dec 4, 2023   
    Clinical development is ongoing for the mobilization of CD34 HSCs for gene therapy in patients with sickle cell disease. This article summarizes the milestones in the development of motixafortide leading to this first approval.
  • ||||||||||  Review, Journal:  IgG4-related disease: A proteiform pathology with frequent chest manifestations (Pubmed Central) -  Dec 4, 2023   
    The favourable capecitabine QOL compared with CMF supports its use as an adjuvant option after neoadjuvant chemotherapy in patients with triple-negative breast cancer. Substantial progress has been made over recent years in understanding IgG4-RD pathophysiology, and personalized patient care seems to be an achievable medium-term goal.
  • ||||||||||  Lumakras (sotorasib) / Amgen
    P1 data, Journal:  First-in-Humans PET Imaging of KRAS Mutation Status in Non-Small Cell Lung and Colorectal Cancer Patients Using [F]PFPMD. (Pubmed Central) -  Dec 4, 2023   
    Substantial progress has been made over recent years in understanding IgG4-RD pathophysiology, and personalized patient care seems to be an achievable medium-term goal. [F]PFPMD was synthesized on the basis of AMG510 (sotorasib) by attaching a polyethylene glycol chain to the quinazolinone structure...The accumulation of [F]PFPMD in KRAS mutation tumors was significantly higher than that in non-KRAS mutation tumors (SUV: 3.73?
  • ||||||||||  camizestrant (AZD9833) / AstraZeneca, Undisclosed CDK4/6 inhibitor / CS Group
    Journal:  The next-generation oral selective estrogen receptor degrader camizestrant (AZD9833) suppresses ER+ breast cancer growth and overcomes endocrine and CDK4/6 inhibitor resistance. (Pubmed Central) -  Dec 4, 2023   
    Evaluation of camizestrant in combination with CDK4/6i (palbociclib or abemaciclib) in CDK4/6-naive and -resistant models, as well as in combination with PI3K?i (alpelisib), mTORi (everolimus), or AKTi (capivasertib), indicated that camizestrant was active with CDK4/6i or PI3K/AKT/mTORi and that antitumor activity was further increased by the triple combination...The response was observed independently of PI3K pathway mutation status. Overall, camizestrant shows strong and broad anti-tumor activity in ER+ breast cancer as a monotherapy and when combined with CDK4/6i and PI3K/AKT/mTORi.
  • ||||||||||  Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
    Journal:  Buds of new bone formation within the femoral head of hip fracture patients coincide with zones of low osteocyte sclerostin. (Pubmed Central) -  Dec 4, 2023   
    Romosozumab treatment reduces the rate of hip fractures and increases hip bone density, increasing bone formation by inhibiting sclerostin protein...FMiS density correlated with greater amount, thickness, number and connectivity of trabeculae (bone volume BV/TV, r?=?0.65, p?<?0.0001; bone surface BS/TV, r?=?0.47, p?<?0.01; trabecular thickness Tb.Th, r?=?0.55, p?<?0.001; trabecular number Tb.N, r?=?0.47, p?<?0.01; and connectivity density Conn.D, r?=?0.40, p?<?0.05) and lower trabecular separation (Tb.Sp, r?=?-0.56, p?<?0.001). These results demonstrate modeling-based bone formation in femoral trabeculae from patients with hip fracture as a potential therapeutic target to enhance bone structure.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Journal:  Follow-up imaging of SAPHO syndrome treated with denosumab. (Pubmed Central) -  Dec 4, 2023   
    Contrary to expectations based on earlier research suggesting that paradoxical reactions develop with the class effect of biological agents, the response of patients who were shifted to another TNFi was favourable. No abstract available
  • ||||||||||  Repatha (evolocumab) / Amgen, Astellas
    Journal:  Analysis of the evolocumab (Repatha (Pubmed Central) -  Dec 4, 2023   
    The overall adherence found was higher than 70%; similar to findings reported in other real-life studies with iPCSK9. However, the reasons for low compliance were different, highlighting the high number of administrative and medical reasons for suspension or abandonment of treatment with evolocumab.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Review, Journal:  Current indications for denosumab in benign bone tumours. (Pubmed Central) -  Dec 1, 2023   
    Data are derived, however, mostly from case reports and case series. Large prospective clinical trials are needed to evaluate the role and also the side effects of denosumab in the treatment of these rare diseases.
  • ||||||||||  Neupogen (filgrastim) / Kyowa Kirin, Amgen, Nivestym (filgrastim-aafi) / Pfizer
    Journal:  Validation of Nivestym compared to Neupogen: An NMDP analysis. (Pubmed Central) -  Dec 1, 2023   
    Large prospective clinical trials are needed to evaluate the role and also the side effects of denosumab in the treatment of these rare diseases. No abstract available
  • ||||||||||  Tepezza (teprotumumab) / Roche, Amgen
    Journal:  The effect of acromegaly on thyroid disease. (Pubmed Central) -  Dec 1, 2023   
    Recent studies have reported that the IGF-1 receptor (IGF-1R) plays an important role in the pathogenesis of TAO, and the IGF-1R inhibitor teprotumumab involves significantly improved disease endpoints in patients with active TAO. Thyroid-stimulating hormone (TSH) receptor (TSHR) and IGF-1R co-immunoprecipitate in orbital and thyroid tissues to form a functional complex; thus, combined therapy targeting TSHR and IGF-1R may be more effective than single therapy.
  • ||||||||||  Ibrance (palbociclib) / Pfizer, Bavencio (avelumab) / EMD Serono, Erbitux (cetuximab) / Eli Lilly
    Trial completion date, Metastases:  Avelumab, Cetuximab, and Palbociclib in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) -  Dec 1, 2023   
    P1,  N=24, Active, not recruiting, 
    Further studies are warranted to better establish the long-term comparative effectiveness, safety, and cost effectiveness of anti-CGRP mAbs compared to other preventive medications. Trial completion date: Jul 2023 --> Dec 2024