Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval.
Sign Up to like & getrecommendations! Published in 2019 at "JAMA internal medicine"
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
Time to Confirmatory Study Initiation After Accelerated Approval of Cancer and Noncancer Drugs in the US.
Sign Up to like & getrecommendations! Published in 2023 at "JAMA internal medicine"
DOI: 10.1001/jamainternmed.2023.0777
Abstract: This cross-sectional study examines and compares the time taken from the accelerated approval of cancer and noncancer drugs to the initiation of confirmatory studies in the US. read more here.
Keywords: time; accelerated approval; cancer noncancer; noncancer drugs ... See more keywords
US Food and Drug Administration Accelerated Approval Program for Nononcology Drug Indications Between 1992 and 2018
Sign Up to like & getrecommendations! Published in 2022 at "JAMA Network Open"
DOI: 10.1001/jamanetworkopen.2022.30973
Abstract: This cohort study evaluates how the US Food and Drug Administration (FDA) accelerated approval program has been used for nononcology drugs over a period of 26 years. read more here.
Keywords: food drug; accelerated approval; approval program; drug administration ... See more keywords
Exposure to US Cancer Drugs With Lack of Confirmed Benefit After US Food and Drug Administration Accelerated Approval
Sign Up to like & getrecommendations! Published in 2023 at "JAMA Oncology"
DOI: 10.1001/jamaoncol.2022.7770
Abstract: This cross-sectional study evaluates patient exposure to oncology drugs withdrawn from the US Food and Drug Administration (FDA) Accelerated Approval program. read more here.
Keywords: oncology; food drug; accelerated approval; drug administration ... See more keywords
Clinical development time is shorter for new anticancer drugs approved via accelerated approval in the US or via conditional approval in the EU.
Sign Up to like & getrecommendations! Published in 2023 at "Clinical and translational science"
DOI: 10.1111/cts.13519
Abstract: The FDA and the EMA offer expedited regulatory approval programs for drugs with high potential patient value applicable at different stages leading to marketing authorization: (i) drug development (fast track designation (FTD), breakthrough therapy designation… read more here.
Keywords: development time; accelerated approval; approval; development ... See more keywords
Drugs with FDA accelerated approval often have weak evidence, study finds
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DOI: 10.1136/bmj.j2905
Abstract: Drugs that receive accelerated approvals from the US Food and Drug Administration often rest on a flawed evidence base, says research that evaluated over 7000 clinical studies conducted on 37 drugs that were given such… read more here.
Keywords: often weak; approval often; accelerated approval; fda accelerated ... See more keywords