Results for 'anticancer drug development'
Emmanuelle Jacqueta, Ghania Kerouani-Lafayeb, Francoise Grudeb, Sergio Goncalvesb, Annie Lorenced, Florence Turcryb, Liora Brunelb, Laetitia Belgodereb, Adrien Monardc, Gaëlle Guyaderb, Lotfi Boudalib, Nicolas Albin
Comparative study on anticancer drug access times between FDA, EMA and the French temporary authorisation for use program over 13 years
Innovation, Expanded access, Early drug access, Cancer, FDA, EMA
Cancer incidence is increasing globally, and while medical innovation significantly impacts patient survival, the drug development process is lengthy, often exceeding 10 years for marketing authorization (MA). France has implemented the ATU (Temporary Authorization for Use) program to facil…
Apr 7th • 12 mins read
Benjamin Gregory Carlisle, Adélaïde Doussau, Jonathan Kimmelman
Patient burden and clinical advances associated with post approval monotherapy cancer drug trials: a retrospective cohort study
clinical advances, monotherapy cancer drug trials, FDA
Objective: The study investigates the efforts to extend the uses of new drugs by testing them for new, non-approved indications and examines the patient burden and clinical impact. Design and Setting: A retrospective cohort study focused on post-approval trials of anticancer drugs approved betwee…
Feb 17th • 7 mins read
Natansh D. Modi, BPharm; Ahmad Y. Abuhelwa, PhD; Ross A. McKinnon, PhD
Audit of Data Sharing by Pharmaceutical Companies for Anticancer Medicines Approved by the US Food and Drug Administration
IPD sharing, clinical trial transparency, FDA anticancer approvals, oncology trials, data accessibility, pharmaceutical industry
The study examines the eligibility for individual participant data (IPD) sharing from clinical trials that supported the FDA approval of anticancer medicines over the past 10 years. Of the 304 trials analyzed, 136 (45%) were eligible for IPD sharing, while 168 (55%) were not. IPD sharing rates v…
Jul 28th • 20 mins read
Yafang Huanga, Weiyi Xiongb, Jingwei Zhaoa, Wentao Lia, Li Mac, Hao Wua
Early phase clinical trial played a critical role in the Food and Drug Administration-approved indications for targeted anticancer drugs: a cross-sectional study from 2012 to 2021
Early phase clinical trial, Dose-expansion cohort, Single-arm trial, Pivotal trial, FDA approved indications, Targeted anticancer drugs
Analysis of 188 FDA-approved indications for 95 molecular targeted anticancer drugs between 2012 and 2021. 59.6% of indications were approved based on Early Phase Clinical Trials (EPCTs). There was a notable annual increase of 22.2% in approvals based on EPCTs, compared to a 5.0% increase for ph…
Mar 9th • 10 mins read
Meena N Murugappan, PharmD, MPH, PhD(c), Bellinda L King-Kallimanis, PhD, Gregory H Reaman, MD, Vishal Bhatnagar, MD, Erica G Horodniceanu, MPH, Najat Bouchkouj, MD, Paul G Kluetz, MD
Patient-Reported Outcomes in Pediatric Cancer Registration Trials: A US Food and Drug Administration Perspective
cancer, pediatrics, product labeling, united states food and drug administration, childhood cancer, denosumab, surrogate endpoints, adverse event, patient self-report, pediatric oncology, selumetinib, benefit-risk assessment, tisagenlecleucel, statistica
PROs have been feasible to collect from patients as young as 7 years old and were included in trials from 2013 onward. PROs were used as exploratory endpoints in four product applications but not included in product labeling. To include PRO data in FDA labeling, early interaction with the FDA, c…
Apr 30th • 12 mins read
Patrick C. DeMartino, MD, Miloš D. Miljković, MD, MS, Vinay Prasad, MD
Potential Cost Implications for All US Food and Drug Administration Oncology Drug Approvals in 2018
FDA, drug approvals, oncology, cancer drugs
The new, expensive cancer drugs approved by the FDA in 2018 could drastically increase U.S. healthcare spending if widely adopted, but industry forecasts suggest low-level market uptake, maintaining current budget trends. The healthcare system's financial stability partially relies on many eligible …
Aug 31st • 7 mins read
Hagop M. Kantarjian MD, Ferran Prat PhD, JD, David P. Steensma MD, Razelle Kurzrock MD, David J. Stewart MD, Mikkael A. Sekeres MD, Joseph Leveque MD
Cancer research in the United States: A critical review of current status and proposal for alternative models
cancer research, research, NCI, Drug industry-driven research model, development in research, 2018 cancer model
Early research focused on tissue histology and animal models, with surgery and radiotherapy as primary treatments. 1950s: Introduction of cell lines (e.g., HeLa cells) and first anticancer drugs (antifolates, thiopurines), leading to the establishment of the Cancer Chemotherapy National Service C…
May 14th • 10 mins read
Stephanie Faucette, Santosh Wagh, Ashit Trivedi, Karthik Venkatakrishnan, Neeraj Gupta
Reverse Translation of US Food and Drug Administration Reviews of Oncology New Molecular Entities Approved in 2011-2017: Lessons Learned for Anticancer Drug Development
clinical pharmacology, FDA reviews, PMR, PMC, molecular entitites, anticancer drug development
The article discusses optimizing oncology drug development, focusing on the impact of pharmacokinetic factors like food effects and drug interactions. It recommends early evaluation of these factors to enhance dosing accuracy and patient compliance. Advanced modeling and simulation are suggested to …
Mar 11th • 15 mins read
Ariadna Tibau, Consolación Molto, Alberto Ocana, Arnoud J Templeton, Luis P Del Carpio, Joseph C Del Paggio, Agustí Barnadas, Christopher M Booth, Eitan Amir
Magnitude of Clinical Benefit of Cancer Drugs Approved by the US Food and Drug Administration
antineoplastic agents, immunologic adjuvants, pharmaceutical adjuvants, phase 3 clinical trials, drug approval, drug labeling, medical oncology, united states food and drug administration, diagnosis, palliative care, surrogate endpoints, weight measureme
Regulatory agencies assess drug safety and efficacy, but thresholds may differ from those accepted by clinicians . Only 43.8% of RCTs for FDA-approved drugs meet the ESMO-MCBS threshold for meaningful benefit, reflecting potential softening of FDA standards. Encouraging trends include an increas…
Dec 13th • 7 mins read
Louis Everest, BSc; Monica Shah, BSc; Kelvin K.W. Chan, MD, MSc, PhD
Comparison of Long-term Survival Benefits in Trials of Immune Checkpoint Inhibitor vs Non-Immune Checkpoint Inhibitor Anticancer Agents Using ASCO Value Framework and ESMO Magnitude of Clinical Benefit Scale
immunotherapy-triggered LTP, RCTs, FDA, ICI
Importance: Anticancer agents, especially immune checkpoint inhibitors (ICIs), have shown potential for long-term durable survival in some patients. However, traditional clinical benefit measures may not accurately capture this, leading to proposed amendments in valuation frameworks. Objectives: …
Jul 10th • 12 mins read
Stefanie Broes, Robbe Saesen, Denis Lacombe, Isabelle Huys
Past, Current, and Future Cancer Clinical Research Collaborations: The Case of the European Organisation for Research and Treatment of Cancer
European organisation for Research and Treatment of Cancer, EORTC, clinical research
Collaborations between academic institutions and industry have led to significant scientific breakthroughs in pharmaceutical research, particularly in the discovery phase. The role of multi-stakeholder partnerships in the clinical development of anticancer medicines requires further clarification…
Aug 16th • 8 mins read
S.F. Oosting, J. Barriuso, A. Bottomley, M. Galotti, B. Gyawali, B. Kiesewetter, N.J. Latino, F. Martinelli, M. Pe, G. Pentheroudakis, F. Roitberg, H. Vachon, E.G.E. de Vries, M. Piccart, N.I. Cherny
Methodological and reporting standards for quality-of-life data eligible for European Society for Medical Oncology-Magnitude of Clinical Benefit Scale
Benefit Scale, MCBS, Quality of Life, Health Assessment, Oncology Scale, Cancer Guidelines, Treatment Evaluation, Medicine Scoring
The ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS) was introduced in 2015 to standardize the assessment of clinical benefits from cancer treatments. ESMO-MCBS helps in health-technology assessment, especially given the increasing number of treatment options and rising cancer care costs. Ne…
Apr 1st • 30 mins read