Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval.
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DOI: 10.1001/jamainternmed.2019.0462
Abstract: Importance The US Food and Drug Administration's (FDA's) accelerated approval pathway allows investigational cancer drugs to be approved by demonstrating a beneficial effect on a surrogate measure (eg, progression-free survival) that is expected to predict… read more here.
Keywords: clinical benefit; cancer drugs; confirmatory trials; accelerated approval ... See more keywords
An Overview of Cancer Drugs Approved by the US Food and Drug Administration Based on the Surrogate End Point of Response Rate.
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DOI: 10.1001/jamainternmed.2019.0583
Abstract: Importance Approximately one-third of cancer drugs are approved based on response rate (RR)-the percentage of patients whose tumors shrink beyond an arbitrary threshold-typically assessed in a single-arm study. Objective To characterize RR end points used… read more here.
Keywords: cancer drugs; response; drug; rate ... See more keywords
Real-world Use of and Spending on New Oral Targeted Cancer Drugs in the US, 2011-2018.
Sign Up to like & getrecommendations! Published in 2021 at "JAMA internal medicine"
DOI: 10.1001/jamainternmed.2021.5983
Abstract: Importance Launch prices of new cancer drugs in the US have substantially increased in recent years despite growing concerns about the quantity and quality of evidence supporting their approval by the US Food and Drug… read more here.
Keywords: cancer drugs; 2011 2018; targeted cancer; cancer ... See more keywords
Association of Adjuvant or Metastatic Setting With Discontinuation of Cancer Drugs in Clinical Trials
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DOI: 10.1001/jamanetworkopen.2022.12327
Abstract: Key Points Question How does the percentage of patients who withdraw from adjuvant trials because of adverse events compare with patients who withdraw from metastatic trials for the same drug? Findings In this cross-sectional study,… read more here.
Keywords: setting discontinuation; adjuvant metastatic; metastatic setting; cancer drugs ... See more keywords
Overall Survival Benefits of Cancer Drugs Approved in China From 2005 to 2020
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DOI: 10.1001/jamanetworkopen.2022.25973
Abstract: Key Points Question What is the overall survival benefit of cancer drugs approved in China between 2005 and 2020? Findings In this mixed-methods study comprising a systematic review and cross-sectional analysis of 78 cancer drugs… read more here.
Keywords: cancer; cancer drugs; drugs approved; approved china ... See more keywords
Assessment of Price and Clinical Benefit of Cancer Drugs in Canada, 2011-2020
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DOI: 10.1001/jamanetworkopen.2022.53438
Abstract: This cohort study examines the association between approval characteristics, clinical benefit, and prices of cancer drugs recommended for reimbursement by the Canadian Agency for Drug and Technology in Health. read more here.
Keywords: assessment price; price clinical; clinical benefit; cancer drugs ... See more keywords
Severe anaphylaxis caused by intravenous anti‐cancer drugs
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DOI: 10.1002/cam4.4252
Abstract: The incidence and risk factors of severe anaphylaxis by intravenous anti‐cancer drugs are unclear, whereas those of milder reactions have been reported. read more here.
Keywords: cancer drugs; severe anaphylaxis; intravenous anti; anaphylaxis caused ... See more keywords
Global system for cancer drug testing and approval is needed
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DOI: 10.1002/cncr.34668
Abstract: I t is an unfortunate reality that not all patients with cancer have access to the drugs that could effectively treat their disease. Creating and implementing a global system for testing and approving cancer therapies… read more here.
Keywords: system; approval; cancer drugs; global system ... See more keywords
Post‐Marketing Requirements for Cancer Drugs Approved by the European Medicines Agency, 2004–2014
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DOI: 10.1002/cpt.2679
Abstract: To address unresolved questions about drug safety and efficacy at the time of approval, the European Medicines Agency (EMA) may require that manufacturers conduct additional studies during the postmarketing period. As a growing proportion of… read more here.
Keywords: medicines agency; european medicines; 2004 2014; cancer drugs ... See more keywords
Childhood Cancer Drugs in China: An Overview and Comparison of Regulatory Approvals in China and the United States.
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DOI: 10.1002/ijc.33818
Abstract: Different from less developed countries, 80% of children with cancers in the US are cured. Traditional chemotherapy drugs are the mainstay of therapies; new targeted medications have become available recently. Using publicly available data, we… read more here.
Keywords: cancer drugs; china overview; drugs china; cancer ... See more keywords
The evidence base of US Food and Drug Administration approvals of novel cancer therapies from 2000 to 2020
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DOI: 10.1002/ijc.34473
Abstract: Concerns have been raised that regulatory programs to accelerate approval of cancer drugs in cancer may increase uncertainty about benefits and harms for survival and quality of life (QoL). We analyzed all pivotal clinical trials… read more here.
Keywords: cancer; evidence base; novel cancer; cancer drugs ... See more keywords