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
Factors in Time to Full Approval or Withdrawal for Anticancer Medicines Granted Accelerated Approval by the FDA
Sign Up to like & getrecommendations! Published in 2025 at "JAMA Network Open"
DOI: 10.1001/jamanetworkopen.2025.2026
Abstract: Key Points Question What factors are associated with the fast conversion of accelerated Food and Drug Administration approval of cancer drugs to regular approval? Findings In this cohort study of 102 cancer drug indications granted… read more here.
Keywords: granted accelerated; accelerated approval; time full; factors time ... See more keywords
Trends in Formulary Coverage of Nonprotected Class Drugs Granted FDA Accelerated Approval
Sign Up to like & getrecommendations! Published in 2025 at "JAMA Network Open"
DOI: 10.1001/jamanetworkopen.2025.36089
Abstract: This cross-sectional study examines the trends in Medicare Part D formulary coverage of nonprotected class drugs granted accelerated approval by the US Food and Drug Administration. read more here.
Keywords: drugs granted; coverage nonprotected; formulary coverage; nonprotected class ... 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
Regulatory Fate of Cancer Indications in the European Union After Accelerated Approval in the US.
Sign Up to like & getrecommendations! Published in 2024 at "JAMA oncology"
DOI: 10.1001/jamaoncol.2024.5145
Abstract: This cohort study investigates the regulatory fate in the European Union for drugs that received accelerated approval for cancer indications in the US. read more here.
Keywords: cancer indications; regulatory fate; european union; accelerated approval ... See more keywords
Changes in Oncology Medication Use After Withdrawal of Accelerated Approval.
Sign Up to like & getrecommendations! Published in 2025 at "JAMA oncology"
DOI: 10.1001/jamaoncol.2025.0359
Abstract: This cohort study assesses changes in cancer drug use after negative confirmatory trials and removal of accelerated approval indications from US Food and Drug Administration–approved labeling. read more here.
Keywords: oncology; medication use; changes oncology; accelerated approval ... See more keywords
Accelerated Approval for Cancer Drugs in the United States and the Clinical Evidence Required for Conversion to Regular Approval
Sign Up to like & getrecommendations! Published in 2024 at "Journal of Pharmaceutical Innovation"
DOI: 10.1007/s12247-024-09851-9
Abstract: Oncology products often leverage accelerated approval program to seek earlier launches in the United States. Little is known about how the Food and Drug Administration (FDA) has been balancing evidence and access, and the factors… read more here.
Keywords: oncology; post accelerated; approval requirements; approval ... See more keywords
The Utilization of the Accelerated Approval Pathway in Oncology: A Case Study of Pembrolizumab
Sign Up to like & getrecommendations! Published in 2024 at "Drugs"
DOI: 10.1007/s40265-024-02111-7
Abstract: The accelerated approval (AA) pathway was established by the United States Food and Drug Administration (FDA) to provide earlier access to therapies for patients with serious medical conditions and unmet medical needs. Since its inception,… read more here.
Keywords: oncology; approval pathway; pembrolizumab; approval ... 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