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
The value of the accelerated approval pathway: real-world outcomes associated with reducing the time between innovations
Sign Up to like & getrecommendations! Published in 2024 at "Future Oncology"
DOI: 10.2217/fon-2023-0514
Abstract: Aim: We investigated the effect of shortening time between innovations with the accelerated approval (AA) pathway on patient outcomes for three solid tumors. Methods: This real-world analysis evaluated patients receiving sequential AA pathway-approved innovations after… read more here.
Keywords: approval pathway; time; time innovations; real world ... See more keywords