Results for 'ASCO'
Vanessa Arciero, BS, Seanthel Delos Santos, Liza Koshy
Assessment of Food and Drug Administration- and European Medicines Agency-Approved Systemic Oncology Therapies and Clinically Meaningful Improvements in Quality of Life: A Systematic Review
ESMO, MCBS, FDA, ASCO-VF, EMA, QOL
Recent oncology therapies approved by the FDA and EMA often lack evidence of clinically meaningful improvements in quality of life (QOL). Only 40% of FDA-approved and 58% of EMA-approved oncology therapies had published QOL evidence. Clinically meaningful QOL improvements beyond minimal dif…
Feb 11th • 4 mins read
Consolación Molto MD, Thomas J. Hwang AB, Maria Borrell MD, Marta Andres MD, Ignasi Gich MD, PhD, Agustí Barnadas MD, PhD, Eitan Amir MD, PhD, Aaron S. Kesselheim MD, JD, MPH, Ariadna Tibau MD, PhD
Clinical benefit and cost of breakthrough cancer drugs approved by the US Food and Drug Administration
USFDA, ESMO-MCBS, NCCN, ASCO-CRC, clinical, drug aroval
The study evaluates the clinical benefit and pricing of breakthrough-designated versus non-breakthrough-designated cancer drugs. The analysis covers approvals from July 2012 to December 2017, using frameworks like ASCO-VF, ASCO-CRC, ESMO-MCBS, and NCCN Evidence Blocks. High clinical benef…
Jul 22nd • 12 mins read
Roman Adam, Ariadna Tibau, Consolación Molto Valiente, Boštjan Šeruga, Alberto Ocaña, Eitan Amir, Arnoud J. Templeton
Clinical benefit of cancer drugs approved in Switzerland 2010–2019
cancer drug approval, clinical benefit criteria, ESMO-MCBS, ASCO-VF, OLUtool, Switzerland oncology drugs
The study evaluates the clinical benefit of cancer drugs approved in Switzerland between 2010 and 2019 using three different frameworks: ESMO-MCBS, ASCO-VF, and OLUtool. A total of 48 drugs for 92 indications were assessed based on 100 studies, with each study evaluated according to the criteria …
Jun 10th • 35 mins read
Consolacion Molto, Ariadna Tibau, Aida Bujosa, Jose Carlos Tapia, Abhenil Mittal, Faris Tamimi & Eitan Amir
Association between control group therapy and magnitude of clinical benefit of cancer drugs
control group therapy, clinical benefit scales, ESMO-MCBS, ASCO-VF, randomized trials
The study investigated the impact of control group therapy on various clinical benefit scales like ASCO-VF, ESMO-MCBS, NCCN Evidence Blocks, and ASCO-CRC. Researchers analyzed cancer drugs approved between 2012 and 2021 using data from randomized controlled trials (RCTs) listed on Drugs@FDA. Sig…
Dec 9th • 20 mins read
Shun-Long Ou, Jing Luo, Hua Wei, Xiao-Li, Qian Jiang
Value assessment of PD-1/PD-L1 inhibitors in the treatment of esophageal and gastrointestinal cancers
PD-1/PD-L1 inhibitors, ESMO-MCBS, ASCO-VF, value, cost
Only a few treatment regimens showed clinical value in EC and CRC using ASCO-VF and ESMO-MCBS frameworks. Nivolumab met valuable threshold in resectable locally advanced EC/GEJC. 14 positive therapeutic regimens assessed; 11 negative regimens showed no improvement in QoL and were below the …
Apr 21st • 13 mins read
Shen Lin, Yaping Huang, Liangliang Dong, Meiyue Li, Yahong Wang, Dian Gu, Wei Wu, Dongni Nian, Shaohong Luo, Xiaoting Huang, Xiongwei Xu and Xiuhua Weng
The correlation between the costs and clinical benefits of PD-1/PD-L1 inhibitors in malignant tumors: An evaluation based on ASCO and ESMO frameworks
PD-1/PD-L1 inhibitors, malignant tumors, ASCO, ESMO, Immune Checkpoint Inhibitors, Gastrointestinal Cancers
Cancer drug innovation has significantly accelerated in the 21st century, with novel drug approvals and expenditures increasing notably. Assessment frameworks ASCO-VF and ESMO-MCBS were used to evaluate the clinical benefit of PD-1/PD-L1 inhibitors, finding that nearly half of the trials met "mea…
Feb 23rd • 9 mins read
Jing Luo, Shunlong Ou, Hua Wei, Xiaoli Qin, Rui Peng, Song Wang and Qian Jiang
Value assessment of NMPA-approved new cancer drugs for solid cancer in China, 2016-2020
cancer drugs, clinical benefit, cost, ASCO-VF, ESMO-MCBS
This study is the first in China to comprehensively evaluate the value of new cancer drugs using ASCO-VF and ESMO-MCBS frameworks and investigate the correlation between drug prices and clinical benefits. Approximately half of the new cancer drugs approved by NMPA between 2016 and 2020 achie…
Feb 24th • 8 mins read
John Devin Peipert, PhD, Karen Kaiser, PhD, Sheetal Kircher, MD, George J. Greene, PhD, Sara Shaunfield, PhD, Katherina Hauner, PhD, David Cella, PhD, and Daniel K. Mroczek, PhD
Medical Oncologists’ Knowledge and Perspectives on the Use of Biosimilars in the United States
oncologist, biosimilars, ASCO, FDA, RSP
Most oncologists (88%) treated patients with biosimilars, and 63% reported that biosimilars were required at their institutions. Approximately half (52%) correctly identified that biosimilars are not the same as generic medicines. Common barriers to biosimilar use included concerns abou…
Jan 9th • 9 mins read
Bishal Gyawali, Benjamin N Rome, Aaron S Kesselheim
Report from American Society of Clinical Oncology Symposium 2020 and American Society of Clinical Oncology Gastrointestinal Cancer Symposium 2021
ASCO, TNT, Gastrointestinal Cancer Symposium
Six out of 18 cancer drugs with accelerated approval still have indications on labeling and are recommended in guidelines despite not showing improvement in primary endpoints in post-approval trials. This issue highlights the imbalance between speed and evidence in the accelerated approval pathwa…
Aug 4th • 13 mins read
Dominic H. Moon, Ronald C. Chen
Defining a Clinically Meaningful Benefit in Cancer Clinical Trials: From the Perspectives of the Clinical Trialist, Patient, and Society
cancer clinical trials, benefit of clinical trials, clinically meaningful, ASCO
In value-based medicine, clinical trials must show both statistically significant and clinically meaningful improvements, such as ASCO's recommendation of a 20% relative improvement in overall survival for metastatic solid tumors. Lawrence et al. found that while many phase III trials met statistica…
Jun 27th • 2 mins read
Ronak Saluja, BS, Louis Everest, Sierra Cheng, Matthew Cheung, MD; Kelvin K. W. Chan, MD, MSc, PhD
Assessment of Whether the American Society of Clinical Oncology's Value Framework and the European Society for Medical Oncology's Magnitude of Clinical Benefit
ASCO, ESMO, value frameworks, randomized controlled trials, ASCO-CBS, ESMO-PMCBG
The ASCO-VF and ESMO-MCBS frameworks currently lack the ability to measure absolute survival benefit, which limits their effectiveness in comparing clinical benefits across different drugs and in establishing value. The authors of the ASCO framework have acknowledged the need for both relative and a…
May 16th • 15 mins read
Di Maria Jiang, Kelvin K. W. Chan, Raymond W. Jang, Christopher Booth, Geoffrey Liu, Eitan Amir, Robert Mason, Louis Everest, Elena Elimova
Anticancer drugs approved by the Food and Drug Administration for gastrointestinal malignancies: Clinical benefit and price considerations
ASCO VF, ESMO MCBS, gastrointestinal malignancies, anticancer drugs
Drugs approved between 2006 and 2017 were analyzed. Clinical benefit was measured using ESMO Magnitude of Clinical Benefit Scale and ASCO Value Framework. 16 GI cancer drugs received FDA approval for 24 indications, including various drug classes such as monoclonal antibodies, oral targeted …
Mar 7th • 8 mins read
M. Bertagnolli and J. Tabernero
Value assessment frameworks in oncology: championing concordance through shared standards
The ASCO Value Framework Net Health Benefit Score (ASCO-NHB) and the ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS), introduced in 2015, are essential tools for assessing the relative benefit of cancer therapies. Both ASCO and ESMO continually refine these frameworks and engage with stakeholde…
Feb 18th • 1 min read
iNIZIO
Expert perspectives live from ASCO® 2025
At the 2025 ASCO® Annual Meeting, three of our experts sat down with OncoDaily to share their unique perspectives in oncology – from amplifying the patient voice to unlocking real-world impact through data and AI. Watch the videos below. Matthew Hoelzle | Medical strategy, AI and real-wor…
Jul 2nd • 1 min 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
iNIZIO
Transforming oncology: Five frontiers driving progress in cancer care
From biomarker-driven breakthroughs to AI-powered early detection and a renewed commitment to equity and patient centricity, the past 12 months have seen major strides across cancer research, treatment, and communication. At Inizio, we’ve had a front-row seat to this transformation, supporting…
May 16th • 5 mins read
Yuan Zhang, Xu Liu, Ying-Qin Li, Ling-Long Tang, Lei Chen, Jun Ma
A Field Test of Major Value Frameworks in Chemotherapy of Nasopharyngeal Carcinoma-To Know, Then to Measure
value framework, European Society for Medical Oncology, Magnitude of Clinical Benefit Scale, American Society of Clinical Oncology, drug therapy, nasopharyngeal neoplasms
The European Society for Medical Oncology (ESMO) and the American Society of Clinical Oncology (ASCO) have developed frameworks to evaluate cancer treatments, particularly for nasopharyngeal carcinoma. A study compared these frameworks using data from 15 randomized controlled trials of systemic c…
Aug 12th • 10 mins read
Shani Paluch-Shimon, Nathan I. Cherny, Elisabeth G.E. de Vries, Urania Dafni, Martine J. Piccart, Nicola Jane Latino, Fatima Cardoso
Application of the ESMO-Magnitude of Clinical Benefit Scale (V.1.1) to the field of early breast cancer therapies
early breast cancer, magnitude of clinical benefit scale, ESMO-MCBS
The ESMO-MCBS is a validated value scale for assessing solid tumour anticancer treatments, specifically for therapies with curative intent. This document represents the first large-scale field testing of the ESMO-MCBS in early breast cancer to assess its applicability and identify any sh…
Sep 6th • 20 mins read
Fei Liang, Sheng Zhang, Qin Wang, Wenfeng Li
Clinical benefit of immune checkpoint inhibitors approved by US Food and Drug Administration
Randomized trials, Clinical benefits, Immune checkpoint inhibitors, Cancer, Food and drug administration agency
The study evaluates the clinical benefits of immune checkpoint inhibitors using the ESMO-MCBS and ASCO VF scales. 18 indications for these inhibitors were approved based on RCTs conducted between 2011 and 2018. All indications meet the ESMO-MCBS 1.1 threshold for meaningful bene…
Aug 31st • 16 mins read
Doreen A. Ezeife MD, Francois Dionne PhD, Aline Fusco Fares MD, Ellen Laura Rose Cusano MD, Rouhi Fazelzad BSc, MISt, Wenzie Ng BSc, MPharm, RPh, Don Husereau BSc Pharm, MSc, Farzad Ali BPharm, MSc, Christina Sit MSc, Barry Stein B.Com BCL, LLB, Jennifer
Value assessment of oncology drugs using a weighted criterion-based approach
anticancer therapy, multicriteria decision analysis, value assessment, value assessment framework
The rising cost of anticancer therapy has led to efforts to quantify the overall value of new cancer treatments. Multicriteria decision analysis is used to incorporate multiple criteria and perspectives into value assessment. A diverse, multistakeholder group developed a drug assessment framewor…
Dec 20th • 15 mins read