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Results for '2020'

Advances in basic research in oncology in 2020: Bridging basic science and clinical care
OVN Avatar Pai, Rekha
Advances in basic research in oncology in 2020: Bridging basic science and clinical care

advances, research, oncology, PCAWG, 2020

Cancer research is advancing with an understanding of the disease at the genetic level, facilitated by massive parallel sequencing. The pan-cancer analysis of the whole genome (PCAWG) in 2020 documented genomic changes across 38 cancer types, involving 2658 cancer genomes. An average of four to …

Mar 24th • 1 min read

Updated estimates of eligibility for and response to genome-targeted oncology drugs among US cancer patients, 2006-2020
OVN Avatar A. Haslam, M.S. Kim, V. Prasad
Updated estimates of eligibility for and response to genome-targeted oncology drugs among US cancer patients, 2006-2020

genome-targeted therapy, eligibility, response

Recent studies have been conducted to update the estimates of eligibility and response rates to genome-targeted therapies among US cancer patients, reflecting data up to 2020. The number of FDA-approved drugs targeting genetic indications has increased significantly since prior assessments. …

Apr 20th • 7 mins read

Overall Survival Benefits of Cancer Drugs Approved in China From 2005 to 2020
OVN Avatar Yichen Zhang, MSc; Huseyin Naci, PhD; Anita K. Wagner, PharmD, DrPH
Overall Survival Benefits of Cancer Drugs Approved in China From 2005 to 2020

cancer drug therapy, overall survival, FDA approvals, surrogate endpoints, EMA approvals, quality of life

The study evaluates the overall survival (OS) benefit of cancer drugs approved in China between 2005 and 2020. Out of 141 cancer drug indications approved, 68 showed a documented overall survival benefit, while 34 did not prolong life. Recent regulatory reforms in China aim to improve the availa…

Aug 10th • 30 mins read

Association Between US Drug Price and Measures of Efficacy for Oncology Drugs Approved by the US Food and Drug Administration From 2015 to 2020
OVN Avatar Miloš D. Miljković, MD, MSc, Jordan E. Tuia, BA, Timothée Olivier, MD
Association Between US Drug Price and Measures of Efficacy for Oncology Drugs Approved by the US Food and Drug Administration From 2015 to 2020

Cancer drug pricing, Cancer care costs, Cancer drug efficacy, Progression-free survival, Value-based pricing in oncology, FDA anticancer approvals

The US has worse cancer-related outcomes compared to other high-income countries and has the highest cost of cancer care globally. High costs may be attributed to the improved efficacy of expensive new cancer drugs, though the relationship between cost and benefit is debated. A study found a lin…

Oct 31st • 10 mins read

Value assessment of NMPA-approved new cancer drugs for solid cancer in China, 2016-2020
OVN Avatar 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

Report from American Society of Clinical Oncology Symposium 2020 and American Society of Clinical Oncology Gastrointestinal Cancer Symposium 2021
OVN Avatar 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

Oncology approvals in 2020: a year of firsts in the midst of a pandemic
OVN Avatar Laleh Amiri-Kordestani & Richard Pazdur
Oncology approvals in 2020: a year of firsts in the midst of a pandemic

oncology approvals, pandemic, FDA, biosimilar, oncology, COVID-19

Despite the global COVID-19 pandemic, 2020 was an active year for the OCE. In 2021, the OCE is engaging in Project 2025, an effort to envision the next 5 years in oncology drug development and leverage our resources and talents to improve collaboration with stakeholders to move the field forward as …

Jan 29th • 4 mins read

Inadequate and delayed characterization of cutaneous reactions for US Food and Drug Administration-approved oncologic drugs from 2011-2020 leading to medication discontinuation
OVN Avatar Jason J. Yang, BS Naomi So, MD Nolan J. Maloney, MD Julia Arzeno, MD Katherine K. Clifton, MD Daniel Q. Bach, MD, MPH
Inadequate and delayed characterization of cutaneous reactions for US Food and Drug Administration-approved oncologic drugs from 2011-2020 leading to medication discontinuation

cutaneous, cutaneous reactions, FDA, oncologic drugs, AE, CenterWatch

Half of clinical trials lack detailed descriptions of rashes; over half discontinue therapy due to rash. There's a 1- to 2-year delay from identifying a rash to fully characterizing it, although this has improved over the last decade. Oncologic therapies are often discontinued without consulti…

Oct 23rd • 4 mins read

MSL Hiring and Recruitment: 5 Ways to Support Diversity and Inclusion
Partner Avatar Tom Caravela
MSL Hiring and Recruitment: 5 Ways to Support Diversity and Inclusion

Medical Science Liaison hiring, diversity and inclusion recruitment, diverse interview panel, employee referral program, diversity sourcing strategies

While the COVID-19 pandemic wreaked havoc on many industries, Medical Science Liaison hiring was steady throughout 2020 and continues to remain strong in 2021. The one change in hiring that has become evident is the increase in recruitment practices that support diversity and inclusion. While we may…

May 19th • 2 mins read

MSL Evolution: New Trends and Titles That May Emerge
Partner Avatar Tom Caravela
MSL Evolution: New Trends and Titles That May Emerge

digital marketing strategies, SEO best practices, content marketing tips, social media optimization, keyword research tools

The COVID-19 pandemic has clearly had a profound impact on Field Medical Affairs. Has the Medical Science Liaison role changed forever? What new titles, trends and opportunities might emerge as a result of the new age for Field Medical and the evolution of the Medical Science Liaison? Is virtual en…

Apr 5th • 1 min read

Medical Oncologists’ Knowledge and Perspectives on the Use of Biosimilars in the United States
OVN Avatar 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

Application of Value Framework to Phase III Trials of Immune Checkpoint Inhibitors in Esophageal and Gastric Cancer
OVN Avatar Rajat Thawani, Neha Agrawal, Nicholas F Taflin, Adel Kardosh, Emerson Y Chen
Application of Value Framework to Phase III Trials of Immune Checkpoint Inhibitors in Esophageal and Gastric Cancer

esophageal cancer, gastric cancer, comparative effectiveness research, outcome assessment, antineoplastic agents, immunotherapy

Immunotherapy checkpoint inhibitors are FDA-approved for first-line metastatic esophageal and gastric cancer, but not all scenarios benefit from non-selective chemo-immunotherapy application. ASCO Net Health scores were consistently higher in esophageal cancer trials compared to gastric cancer tr…

Jan 13th • 8 mins read

Building a Healthcare Alliance for Resourceful Medicine Offensive Against Neoplasms in Hematology Added Value Framework for Hematologic Malignancies: A Comparative Analysis of Existing Tools
OVN Avatar Francesco Cerisoli, PhD, Farzad Ali, MSc, Tamás Bereczky, MA, PhD, Natacha Bolaños, BS, Lars Bullinger, MD, Sujith Dhanasiri, MPhil, MSc, James Gallagher, PhD, Sonia García Pérez, MSc, Jan Geissler, MiBA, Yann Guillevic, DEA, Kathryn Harrison, PhD, Anasta
Building a Healthcare Alliance for Resourceful Medicine Offensive Against Neoplasms in Hematology Added Value Framework for Hematologic Malignancies: A Comparative Analysis of Existing Tools

clinical value framework, hematology, Healthcare Alliance for Resourceful Medicine, Offensive Against Neoplasms in hematology, patient-reported outcomes, HARMONY, analysis

Current Value Frameworks (VFs) have limitations and do not meet HARMONY's ambitions for assessing the therapeutic/clinical value of innovative health technologies. There is a need for a cross-stakeholder agreement on the definition of "value," which varies among patients, clinicians, and payers. …

May 17th • 12 mins read

Estimated Medicare Spending on Cancer Drug Indications With a Confirmed Lack of Clinical Benefit After US Food and Drug Administration Accelerated
OVN Avatar Mahnum Shahzad, BA, Huseyin Naci, MHS, PhD, Anita K. Wagner, PharmD, MPH, DrPH
Estimated Medicare Spending on Cancer Drug Indications With a Confirmed Lack of Clinical Benefit After US Food and Drug Administration Accelerated

medicare spending, drug indications, AA, FDA, medicare, ODAC

Medicare Parts B and D spent at least $569 million between 2017 and 2019 on 10 cancer drug indications without confirmed overall survival (OS) benefit after accelerated approval (AA). Approximately $224 million was spent on drug indications that were either voluntarily withdrawn or recommended fo…

Oct 18th • 5 mins read

The Inclusion of Women in Global Oncology Drug Trials Over the Past 20 Years
OVN Avatar Kristina Jenei, BSN, MS, Daniel E. Meyers, MD, MS, Vinay Prasad, MD, MPH
The Inclusion of Women in Global Oncology Drug Trials Over the Past 20 Years

inclusion, woman, global, oncology drug trials, NIH

Women represented 77% of newly diagnosed thyroid cancer cases in 2020 but only comprised 51% of participants in related trials. Women accounted for 48% of global colon cancer cases but only 33% of trial participants for colon cancer therapeutics. Higher enrollment of women in NIH-funded studies …

Aug 26th • 2 mins read

Potential Cost Implications for All US Food and Drug Administration Oncology Drug Approvals in 2018
OVN Avatar 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

Anticancer drugs approved by the Food and Drug Administration for gastrointestinal malignancies: Clinical benefit and price considerations
OVN Avatar 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

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