RE:RE:RE:RE:How does Accelerated Approval work June 20, 2024 - FDA CBER (biologics) Director speaks to another accelerated approval pathway for rare diseases under the Promising Pathway Act, which has been introduced in both chambers of Congress.
[ Pancreatic cancer is considered a rare disease, accounting to 3% of all cancers in the United States ]
https://www.elcaminohealth.org/stay-healthy/blog/pancreatic-cancer-rare-and-little-known-disease#:~:text=Considering%20that%20pancreatic%20cancer%20is,to%20the%20American%20Cancer%20Society.
The US Food and Drug Administration’s (FDA) top biologics official said the proposed Promising Pathways Act would lower the bar for approving treatments for rare diseases and that the existing accelerated approval pathway suffices in bringing treatments to the market that fulfill unmet medical needs.
Speaking at the DIA 2024 Global Annual Meeting on 18 June, Peter Marks, director of the Center for Biologics Evaluation and Research (CBER), was asked to address the status of the accelerated approval pathway, as well as the changes to the program prompted by the Food and Drug Omnibus Reform Act (FDORA).
Marks, along with other experts on the panel, reiterated his support for the accelerated approval program for bringing rare disease and other treatments for unmet medical needs to market.
The accelerated approval program is available to drugs that treat serious or life-threatening conditions that fulfill unmet medical needs. It allows FDA to approve drugs based on a surrogate or intermediate endpoint until confirmatory studies are completed to show a drug’s clinical effectiveness.