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Results for 'Cancer Guidelines'

The First 2 Years of Biosimilar Epoetin for Cancer and Chemotherapy-Induced Anemia in the U.S.: A Review from the Southern Network on Adverse Reactions
OVN Avatar Charles L. Bennett , Sumimasa Nagai , Andrew C. Bennett , Shamia Hoque , Chadi Nabhan , Martin W. Schoen , William J. Hrushesky , Stefano Luminari , Paul Ray , Paul R. Yarnold , Bart Witherspoon , Josh Riente , Laura Bobolts , John Brusk , Rebecca Tombles
The First 2 Years of Biosimilar Epoetin for Cancer and Chemotherapy-Induced Anemia in the U.S.: A Review from the Southern Network on Adverse Reactions

Epoetin, Biosimilars, Interchangeable, Substitution, Guidelines

Biosimilars are biologic drug products similar to reference drugs in various attributes, including safety and efficacy. Biosimilar epoetin was approved by the FDA in 2018 after previous non-approval letters in 2015 and 2017 despite positive reviews by the FDA's Oncologic Drugs Advisory Committee …

Mar 12th • 7 mins read

Safeguarding cancer research funding by European charities amidst the COVID-19 pandemic
OVN Avatar Ioannis Tsagakis and Maria Papatriantafyllou
Safeguarding cancer research funding by European charities amidst the COVID-19 pandemic

cancer charities, cancer research, COVID‐19, funding, pandemic, policy, AECC, AIRC

The COVID-19 outbreak has had a significant impact on cancer research and cancer care. European cancer charities are required to reassess their strategies. There is a need to safeguard income and provide support to cancer researchers. It is crucial to sustain cancer research funding during thes…

Nov 22nd • 3 mins read

Biosimilars in oncology: key role of nurses in patient education
OVN Avatar Cornelius F Waller & Adriano Friganovi´c
Biosimilars in oncology: key role of nurses in patient education

biologics, biosimilars, cancer care, nurse

Biosimilars can reduce costs and improve access to cancer therapies, but unfamiliarity may hinder their adoption. Nurses, as trusted healthcare providers, are crucial in educating patients about biosimilars. Biosimilars are highly regulated and offer benefits comparable to existing biologic…

Jun 15th • 10 mins read

Proportion of Patients in Phase I Oncology Trials Receiving Treatments That Are Ultimately Approved
OVN Avatar Sean X Zhang, MSc , Dean Fergusson, PhD , Jonathan Kimmelman, PhD
Proportion of Patients in Phase I Oncology Trials Receiving Treatments That Are Ultimately Approved

cancer, biological markers, phase 1 clinical trials, drug approval, medical oncology, united states food and drug administration guidelines, adverse event, national comprehensive cancer network, American society of clinical oncology

Phase I oncology trials are often considered a therapeutic option, but this claim is primarily based on surrogate measures like objective response rates. A systematic search was conducted to evaluate the therapeutic value of phase I cancer trial participation, focusing on the likelihood of patien…

Apr 1st • 14 mins read

Patient burden and clinical advances associated with post approval monotherapy cancer drug trials: a retrospective cohort study
OVN Avatar 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

Level of evidence used in recommendations by the National Comprehensive Cancer Network (NCCN) guidelines beyond Food and Drug Administration approvals
OVN Avatar R. Kurzrock, L.A. Gurski, R.W. Carlson, D.S. Ettinger, S.M. Horwitz, S.K. Kumar, L. Million, M. von Mehren, A.B. Benson III
Level of evidence used in recommendations by the National Comprehensive Cancer Network (NCCN) guidelines beyond Food and Drug Administration approvals

oncology, guidelines, off-label drug use

The analysis reviewed 113 NCCN recommendations, focusing on 44 off-label uses of drugs. 14 of these off-label recommendations were later FDA-approved or backed by RCT data. 13 recommendations were minor extrapolations from the FDA label or actually on-label. Of the remaining 17 extrapolations…

Aug 2nd • 8 mins read

FDA validation of surrogate endpoints in oncology: 2005–2022
OVN Avatar Anushka Walia, Alyson Haslam, Vinay Prasad
FDA validation of surrogate endpoints in oncology: 2005–2022

FDA drug approval, surrogate endpoints, oncology drugs, overall survival correlation, clinical trials analysis, drug approval guidelines

ere are summary bullets based on the provided text: The FDA has increasingly approved oncologic drugs based on surrogate endpoints, which often lack a demonstrated correlation with clinically meaningful outcomes like overall survival. A review of FDA analyses from 2005 to 2022 examined the valid…

Dec 1st • 20 mins read

Oncology biosimilars: New developments and future directions
OVN Avatar Rinda Devi Bachu, Mariam Abou-Dahech, Swapnaa Balaji, Sai H. S. Boddu, Samson Amos, Vishal Singh, R. Jayachandra Babu, Amit K. Tiwari
Oncology biosimilars: New developments and future directions

biologics in cancer treatment, biosimilars development, high cost of biologics, healthcare system burden, biosimilars safety, regulatory guidelines for biosimilars, immunogenicity concerns, pharmacoeconomics of biosimilars

Biologics are essential in cancer treatment as both therapeutic and supportive care agents, but they are expensive and require extensive testing to ensure safety. The high cost of developing and manufacturing biologics can be a burden on healthcare systems, limiting patient access to necessary tr…

Nov 25th • 30 mins read

Methodological and reporting standards for quality-of-life data eligible for European Society for Medical Oncology-Magnitude of Clinical Benefit Scale
OVN Avatar 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

Off-label despite high-level evidence: a clinical practice review of commonly used off-patent cancer medicines
OVN Avatar G. Zarkavelis A.L. Amylidi C. Verbaanderd N.I. Cherny Y. Metaxas E.G.E. de Vries P. Zygoura T. Amaral K. Jordan M. Strijbos U. Dafni N. Latino M. Galotti F. Lordick R. Giuliani F. Pignatti G. Pentheroudakis
Off-label despite high-level evidence: a clinical practice review of commonly used off-patent cancer medicines

off-label, ESMO-MCBS, EMA, cancer, ESMO Clinical Practice Guidelines

Several 'old' cancer medicines remain off-label despite strong scientific evidence supporting their use in specific settings. Off-label prescriptions often carry administrative and legal burdens for physicians, affecting workflows and potentially patient access to safe and effective therapies. R…

Nov 14th • 21 mins read

Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study
OVN Avatar Bishal Gyawali, Benjamin N Rome, Aaron S Kesselheim
Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study

clinical guidelines, FDA, accelerated approval cancer drugs, surrogate measures, NCCN, EMA

Six of 18 cancer drugs that initially received accelerated approval have indications that remain on the labeling and are recommended in clinical guidelines despite no improvement in the primary endpoint in post-approval trials. These findings reflect the lack of fulfillment of the compromise between…

Aug 4th • 12 mins read

Recent eUpdates to the ESMO Clinical Practice Guidelines on hepatocellular carcinoma, cancer of the pancreas, soft tissue and visceral sarcomas, cancer of the prostate and gastric cancer
OVN Avatar G. Pentheroudakis
Recent eUpdates to the ESMO Clinical Practice Guidelines on hepatocellular carcinoma, cancer of the pancreas, soft tissue and visceral sarcomas, cancer of the prostate and gastric cancer

ESMO, hepatocellular carcinoma, gastric cancer, prostate cancer

The following ESMO Clinical Practice Guidelines have been recently updated with new treatment recommendations for the ESMO Clinical Practice Guidelines on Hepatocellular Carcinoma, Cancer of the Pancreas, Soft Tissue and Visceral Sarcomas, Cancer of the Prostate and Gastric Cancer.

Jun 6th • 2 mins read

Are the chronological age cutoffs used in clinical oncology guidelines biologically meaningful?
OVN Avatar Neil Carleton and Priscilla F. McAuliffe
Are the chronological age cutoffs used in clinical oncology guidelines biologically meaningful?

Age, cutoffs, clinical oncology guide, biomarkerslines

Age is a significant risk factor for cancer, influencing tumour biology, treatment recommendations, and therapy response. Breast cancer incidence peaks around 70 years of age, with over one-third of diagnoses in this age group. Clinical guidelines vary in defining "older" patients, using …

Dec 1st • 4 mins read

Biases in study design, implementation, and data analysis that distort the appraisal of clinical benefit and ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS) scoring
OVN Avatar B. Gyawali, E. G. E. de Vries, U. Dafni, T. Amaral, J. Barriuso, J. Bogaerts, A. Calles, G. Curigliano, C. Gomez-Roca, B. Kiesewetter, S. Oosting, A. Passaro, G. Pentheroudakis, M. Piccart, F. Roitberg, J. Tabernero, N. Tarazona, D. Trapani, R. Wester, G.
Biases in study design, implementation, and data analysis that distort the appraisal of clinical benefit and ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS) scoring

ESMO-MCBS, bias, clinical trial design, clinical trial implementation, clinical trial reporting, clinical trial analysis

The ESMO-MCBS is a tool used for scoring the clinical benefit of cancer medicines as reported in clinical trials, assuming valid research methodologies and quality implementation. The tool's effectiveness is compromised by studies with flawed design, implementation, or data analysis, w…

Apr 20th • 8 mins read

Clinical development success rates and social value of pediatric Phase 1 trials in oncology
OVN Avatar Mateusz T. Wasylewski, Karolina Strzebonska, Magdalena Koperny, Maciej Polak, Jonathan Kimmelman, Marcin Waligora
Clinical development success rates and social value of pediatric Phase 1 trials in oncology

pediatric oncology, clinical development, trials, success rates

Pediatric Phase 1 trials in oncology aim to assess social value, focusing on rates of approval, transition to further phases, and citation in research. The study analyzed trials from 2004 to 2013, utilizing data from FDA, EMA, ClinicalTrials.gov, EU Clinical Trials Register, and Google Scholar. …

Jun 21st • 28 mins read

EHA evaluation of the ESMO-Magnitude of Clinical Benefit Scale version 1.1 (ESMO-MCBS v1.1) for hematological malignancies
OVN Avatar Barbara Kiesewetter , Nathan I Cherny, Nicolas Boissel, Francesco Cerisoli, Urania Dafni, Elisabeth G E de Vries, Paolo Ghia, Nicola Gökbuget, Verónica González-Calle, Brian Huntly, Ulrich Jäger, Nicola Jane Latino, Jean-Yves Douillard, Luca Malcovati, Ma
EHA evaluation of the ESMO-Magnitude of Clinical Benefit Scale version 1.1 (ESMO-MCBS v1.1) for hematological malignancies

ESMO, hematological malignancies, Clinical benefit scale, EHA

The ESMO-MCBS v1.1 has not been previously validated for haematological malignancies, but it is being explored to avoid duplication of efforts. A feasibility test was conducted using 80 studies related to various haematological malignancies such as acute and chronic leukaemia, lymphoma, myel…

Jan 20th • 20 mins read

Patient involvement: A must-have in medicine development, but is it being overlooked in a cost-constrained environment?
Partner Avatar Envision Pharma Group
Patient involvement: A must-have in medicine development, but is it being overlooked in a cost-constrained environment?

patient engagement in pharma, patient-centric drug development, life sciences industry innovation, patient insights in medicine, regulatory compliance in patient engagement, patient involvement in clinical trials, benefits of patient advocacy, patient-cen

The life sciences industry is in a constant state of advancement, bringing more and more groundbreaking medicines, cutting-edge technologies, and innovative solutions to market. Amidst these rapid changes, patients remain at the heart of these scientific developments. In recent decades, the l…

May 9th • 5 mins read

Evaluating External Validity of Oncology Biosimilar Safety Studies
OVN Avatar Gregory S. Calip, PharmD, MPH, PhD, Ivy P. Altomare, MD, Jenny S. Guadamuz, MSPH, PhD
Evaluating External Validity of Oncology Biosimilar Safety Studies

biologics, external validity, FDA, biosimilars, trastuzumab

Biologics are the fastest growing medication class in the US, significantly contributing to healthcare costs. The Biologics Price Competition and Innovation Act of 2009 created an abbreviated approval pathway to make biological products more accessible. A phase 3 randomized trial of SB3, a trast…

Apr 6th • 2 mins read

Assessment of gender representation in clinical trials leading to FDA approval for oncology therapeutics between 2014 and 2019: A systematic review-based cohort study
OVN Avatar Kyle A. Dymanus BS, Mohit Butaney MBBS, Diana E. Magee MD, MPH, MSc, Amanda E. Hird MD, MSc, Amy N. Luckenbaugh MD, Merry W. Ma MD, PhD, Mary E. Hall MD, Heather L. Huelster MD, Aaron A. Laviana MD, MBA, Nancy B. Davis MD, Martha K. Terris MD, Zachary Kla
Assessment of gender representation in clinical trials leading to FDA approval for oncology therapeutics between 2014 and 2019: A systematic review-based cohort study

clinical trials, drug approval, health care disparities, medical oncology, sexism

Gender representation in oncology clinical trials varies by cancer type, with women often underrepresented compared to national cancer incidence. Despite FDA guidelines from June 2015 requiring consideration of biological variables like sex in research designs, disparities persist. Women continu…

Jun 23rd • 8 mins read

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