Results for 'cancer drugs'
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
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
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
Tanja Cufer, Tudor E. Ciuleanu, Peter Berzinec, Gabriela Galffy, Marko Jakopovic, Jacek Jassem, Dragana Jovanovic, Zhasmina Mihaylova, Gyula Ostoros, Christiane Thallinger, Milada Zemanova, Christoph Zielinski
Access to Novel Drugs for Non-Small Cell Lung Cancer in Central and Southeastern Europe: A Central European Cooperative Oncology Group Analysis
Health Outcomes and Economics of Cancer Care, Lung Cancer, NSCLC, EMA
Treatment for non-small cell lung cancer (NSCLC) has significantly improved with the introduction of targeted and immune-oncologic drugs. Despite rapid development and European Medicinal Agency (EMA) registration, these novel drugs are not easily accessible in Central and Eastern European (CEE) c…
Nov 24th • 10 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
Kelvin Chan, Seungree Nam, Bill Evans, Claire de Oliveira Alexandra Chambers, Scott Gavura, Jeffrey Hoch, Rebecca E Mercer, Wei Fang Dai, Jaclyn Beca, Mina Tadrous, Wanrudee Isaranuwatchai
Developing a framework to incorporate real-world evidence in cancer drug funding decisions: the Canadian Real-world Evidence for Value of Cancer Drugs (CanREValue) collaboration
RWD, Canadian Real World Evidence, cancer drug, funding, framework
Oncology therapy is becoming more expensive, challenging the affordability and sustainability of drug programs globally. Health technology assessment organizations use clinical trials for drug funding decisions, which may not reflect real-world outcomes. The Canadian Real-world Evidence for Valu…
Jan 7th • 8 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
Kenji Omae, Yuki Kataoka, Yasushi Tsujimoto, Yusuke Tsutsumi, Yosuke Yamamoto, Shunichi Fukuhara, Toshi A Furukawa
Publication statuses of clinical trials supporting FDA-approved immune checkpoint inhibitors: a meta-epidemiological investigation
Anticancer drugs, Clinical trials, Drug approval, Immune checkpoint inhibitors, Publications, United states food and drug administration
The study investigates the publication status of clinical trials for anticancer drugs approved by the FDA, focusing on immune checkpoint inhibitors (ICPis). Data from ICPis approved between 2011 and 2014 was analyzed, revealing that 58% of ICPis trials were published within two years …
Oct 24th • 18 mins read
Mark Verrill, Paul Declerck, Sibylle Loibl, Jake Lee & Javier Cortes
The rise of oncology biosimilars: from process to promise
biologic, biosimilar, breast cancer, SB3, trastuzumab
Biosimilars are biologic products that are highly similar to the approved originator molecule, with no clinically meaningful differences. They are expected to play a key role in cancer treatment by reducing costs and improving access. Regulatory bodies use robust mechanisms for approval, involvi…
Aug 23rd • 18 mins read
Idine Mousavi, BA; Timothée Olivier, MD; Vinay Prasad, MD, MPH
Cost per Event Averted in Cancer Trials in the Adjuvant Setting From 2018 to 2022
anticancer drugs, adjuvant therapy, FDA approvals, cost per event averted, surrogate endpoints, oncology drug costs
Importance: Evaluating the cost-effectiveness of adjuvant therapies based on the cost per event averted. Objective: To assess the costs per event averted for anticancer drugs approved by the FDA between January 2018 and March 2022. Design, Setting, and Participants: Cross-sectional study of F…
Jun 10th • 30 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
Christopher A. Busch, MSC; Johannes Krisam, PhD; Meinhard Kieser, PhD
A Comprehensive Comparison of Additional Benefit Assessment Methods Applied by Institute for Quality and Efficiency in Health Care and European Society for Medical Oncology for Time-to-Event Endpoints After Significant Phase III Trials—A Simulation Study
cancer drug trials, time-to-event endpoints, overall survival, added benefit assessment, IQWiG, hazard ratio thresholds
The European Society for Medical Oncology (ESMO) and the German Institute for Quality and Efficiency in Health Care (IQWiG) use different methods for assessing additional benefit in cancer therapies, with ESMO considering both relative and absolute benefits, while IQWiG focuses on the upper limit …
Jun 28th • 30 mins read
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
Rachel E. Sachs, JD, MPH, Kyle A. Gavulic, BA, Julie M. Donohue, PhD
Recent Trends in Medicaid Spending and Use of Drugs With US Food and Drug Administration Accelerated Approval
FDA accelerated approval, Medicaid spending, prescription drug costs, surrogate endpoints, cancer drugs, drug approval pathway
The study examines the impact of drugs approved through the FDA’s accelerated approval program on state Medicaid spending. From 1992 to 2020, 216 drug-indication pairs were granted accelerated approval, with a significant increase in cancer drug approvals in recent years. Although drugs wi…
Oct 8th • 25 mins read
Robbe Saesen, Georgios Kantidakis, Ann Marinus, Denis Lacombe, Isabelle Huys
How do cancer clinicians perceive real-world data and the evidence derived therefrom? Findings from an international survey of the European Organisation for Research and Treatment of Cancer
real-world evidence, real-world data, oncology, cancer, survey, clinicians, randomized controlled trials, Europe
Real-world evidence (RWE) is increasingly being used in the development and decision-making processes for anticancer therapies, but clinician views on its use are unclear. A survey conducted between May and July 2021 involved 557 clinicians from 30 countries and 13 cancer domains. Most clinician…
Aug 1st • 45 mins read
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
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
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
Ravi B. Parikh, MD, MPP Rebecca A. Hubbard, PhD Erkuan Wang, MA Trevor J. Royce, MD, MPH Aaron B. Cohen, MD, MSCE Amy S. Clark, MD, MSCE Ronac Mamtani, MD, MSCE
Exposure to US Cancer Drugs With Lack of Confirmed Benefit After US Food and Drug Administration Accelerated Approval
US, FDA, approval, drugs, benefits, cancer
Among 5 oncology indications, 26.1% of eligible treatment initiations involved an Accelerated Approval (AA) indication that was later withdrawn due to lack of benefit. There is an inherent trade-off between expediting access to promising cancer drugs and the potential withdrawal of some indicatio…
Dec 8th • 2 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