Adstiladrin (nadofaragene firadenovec-vncg) / Ferring 
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  • ||||||||||  Adstiladrin (nadofaragene firadenovec-vncg) / Ferring, Keytruda (pembrolizumab) / Merck (MSD)
    Review, Journal:  BCG and Alternative Therapies to BCG Therapy for Non-Muscle-Invasive Bladder Cancer. (Pubmed Central) -  Feb 27, 2024   
    Moreover, recent logistic issues with BCG production caused a worldwide BCG shortage, re-sparking interest in alternative BCG treatments including mitomycin C, sequential gemcitabine with docetaxel, and others. This review encompasses both the historic and current role of BCG in the treatment of non-muscle-invasive bladder cancer, revisiting BCG alternative therapies and reviewing the novel therapeutics that were approved for the BCG-unresponsive stage or are under active investigation.
  • ||||||||||  Adstiladrin (nadofaragene firadenovec-vncg) / Ferring
    Trial completion date, Trial primary completion date, Real-world evidence, Real-world:  ABLE-41: ADSTILADRIN Early Utilization and Outcomes in the Real World Setting (clinicaltrials.gov) -  Feb 15, 2024   
    P=N/A,  N=800, Recruiting, 
    This review encompasses both the historic and current role of BCG in the treatment of non-muscle-invasive bladder cancer, revisiting BCG alternative therapies and reviewing the novel therapeutics that were approved for the BCG-unresponsive stage or are under active investigation. Trial completion date: Dec 2026 --> Dec 2025 | Trial primary completion date: Dec 2026 --> Dec 2025
  • ||||||||||  Adstiladrin (nadofaragene firadenovec-vncg) / Ferring, Keytruda (pembrolizumab) / Merck (MSD)
    Review, Journal, PD(L)-1 Biomarker, IO biomarker:  Novel immunotherapeutic options for BCG-unresponsive high-risk non-muscle-invasive bladder cancer. (Pubmed Central) -  Jan 2, 2024   
    Despite the challenges faced in finding effective therapies, many potential treatments are currently under investigation. Addressing the landscape of biomarkers, mechanisms of progression, BCG resistance, and trial design challenges in HR-NMIBC is essential for the discovery of new targets and the development of effective treatments.
  • ||||||||||  Adstiladrin (nadofaragene firadenovec-vncg) / Ferring
    ABLE-41: Nadofaragene firadenovec-vncg early use and outcomes in a real-world setting in the United States. (Level 1, West Hall; Poster Bd # M5) -  Dec 13, 2023 - Abstract #ASCOGU2024ASCO_GU_660;    
    P
    The estimated follow-up period is 24 months, until study discontinuation, or withdrawal. Final results from this large, prospective, multi-institutional, real-world registry providing early use and outcomes of nadofaragene firadenovec are expected December 2026.
  • ||||||||||  Adstiladrin (nadofaragene firadenovec-vncg) / Ferring
    Enrollment open, Real-world evidence, Real-world:  ABLE-41: ADSTILADRIN Early Utilization and Outcomes in the Real World Setting (clinicaltrials.gov) -  Sep 28, 2023   
    P=N/A,  N=800, Recruiting, 
    uMRD-determined pre-treatment disease burden assessment can support stratification of control and intervention arms in future treatment trials. Not yet recruiting --> Recruiting
  • ||||||||||  Adstiladrin (nadofaragene firadenovec-vncg) / Ferring
    Review, Journal, Gene therapy:  Interferon gene therapy with nadofaragene firadenovec for bladder cancer: from bench to approval. (Pubmed Central) -  Sep 18, 2023   
    Ongoing research focuses on improving patient selection, identifying biomarkers for response prediction, exploring alternative vectors for enhanced transfection efficiency, and developing combination strategies targeting resistance mechanisms. The approval of nadofaragene firadenovec marks a significant milestone in the field of gene therapy for bladder cancer, and future developments hold promise for further enhancing its efficacy and impact.
  • ||||||||||  Adstiladrin (nadofaragene firadenovec) / Ferring
    Review, Journal:  Nadofaragene Firadenovec: First Approval. (Pubmed Central) -  Mar 24, 2023   
    In December 2022, nadofaragene firadenovec received its first global approval in the USA for the treatment of high-risk BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without papillary tumours in adults. This article summarizes the milestones in the development of nadofaragene firadenovec leading to this first approval for this indication.
  • ||||||||||  Adstiladrin (nadofaragene firadenovec) / Ferring
    Journal, Gene therapy:  In brief: Adstiladrin - a gene therapy for bladder cancer. (Pubmed Central) -  Mar 7, 2023   
    Given the considerable uncertainty around currently available cost-effectiveness estimates, further research could be valuable to guide decision making. No abstract available
  • ||||||||||  MODULE 1: Integrating Novel Treatment Strategies into the Management of Nonmetastatic Urothelial Bladder Cancer (UBC) (San Francisco Marriott Marquis, Yerba Buena ) -  Feb 2, 2023 - Abstract #ASCOGU2023ASCO_GU_927;    
    CME Provider and Supporter(s): This event is organized and accredited by Research to Practice and supported through educational grants provided by Astellas and Seagen Inc, AstraZeneca Pharmaceuticals LP, Gilead Sciences Inc, and Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC. Selection of patients with high-risk non-muscle-invasive bladder cancer (NMIBC) for pembrolizumab therapy Clinical trial findings leading to the recent FDA approval of nadofaragene firadenovec for patients with BCG-unresponsive NMIBC Key efficacy and safety data from the Phase III CheckMate 274 trial comparing nivolumab to placebo after radical surgery for high-risk muscle-invasive bladder cancer (MIBC) Identification of candidates for adjuvant nivolumab and optimal integration of this agent into current clinical practice Rates of pathologic complete response and other clinically relevant endpoints achieved in early trials of neoadjuvant anti-PD-1/PD-L1 antibody therapy for resectable MIBC Ongoing studies evaluating anti-PD-1/PD-L1 antibody-based approaches for nonmetastatic UBC (eg, POTOMAC, ALBAN, KEYNOTE-676, NIAGARA, ENERGIZE, VOLGA, KEYNOTE-866, KEYNOTE-905/EV-303) Mechanism of antitumor activity of the novel intravesical drug delivery system TAR-200; early data in MIBC Ongoing studies of TAR-200 for NMIBC and MIBC (eg, SunRISe-1, SunRISe-2, SunRISe-4)