Results for 'pembrolizumab'
Ali Raza Khaki
Loose Regulatory Standards Portend a New Era of Imprecision Oncology
precision oncology, TMB-high, homologous recombination deficiency, Olaparib, pembrolizumab
Precision oncology aims to tailor cancer treatment based on genetic understanding, revolutionizing oncology. The FDA has been approving drugs under precision oncology with broad indications that may not align with studied populations. Examples include the approval of pembrolizumab for a wide ran…
Dec 1st • 4 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
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
M. Ochoa de Olza, M. Oliva, C. Hierro I. Matos, J. Martin-Liberal, E. Garralda
Early-drug development in the era of immuno-oncology: are we ready to face the challenges?
immunotherapy, early-drug development, toxicology studies, dose determination
The classical development of drugs is being replaced by a seamless drug-development process. First-in-human trials now often include large expansion cohorts to quickly identify early signs of activity and achieve rapid regulatory approval. Intense competition among pharmaceutical companies and t…
Jun 26th • 26 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
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
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
Kirsten B Goldberg, Gideon M Blumenthal, Amy E McKee and Richard Pazdur
The FDA Oncology Center of Excellence and Precision Medicine
Biomarkers, drugs, hematology, medicine, oncology, precision medicine, regulation
The FDA is exploring real-world evidence to enhance understanding of the long-term safety and efficacy of oncology drugs. Initiatives like the Information Exchange and Data Transformation initiative are building infrastructure for big-data analytics. Additionally, patient-focused programs aim to inc…
Nov 6th • 3 mins read