P119: Analysis of Approval Regulations of Colorectal Cancer Drugs in the United States: Twenty-Year Retrospective Study

Poster Presenter

Salman Alharthi

Head of Formulary Management
Security Forces Hospital
Saudi Arabia

Objectives

To examine comprehensively how the FDA’s expedited programs have played a role in the approval of CRC drugs and determine the use of these regulatory pathways during the period from 2003 to 2023.

Method

Utilizing a retrospective methodology; Information for each drug approved for the CRC treatment from 2003 to 2023 was collected from the FDA website and the Drugs@FDA. Descriptive analyses. All the analyses were conducted using Microsoft Excel 2019.

Results

The FDA approved twelve CRC drugs with different active ingredients from 2003 to 2023. All drugs were approved using one or more expedited programs. The expedited programs included Fast Track for nine drugs; Accelerated Approval for seven drugs; Priority Review for ten drugs and Breakthrough Therapy for four drugs. The median time from Fast Track designation to New Drug Application (NDA)/Biologics License Application (BLA) submission was 7.2 months (range, 1.5–31 months). The median time from Accelerated Approval to verification of benefit was 6 years (range, 3.2–8.4 years). The median approval process duration for CRC indications using a Priority Review system was 6.0 months (range = 1.5–6.2 months). 66.6% of the approved CRC drugs were based on data and results from a single trial followed by 25% of CRC drugs approval based on two clinical trials and 8.33% of CRC drugs approved from three clinical trials.

Conclusion

This study showed that the FDA’s expedited programs have played a role in the increased and faster approval of CRC drugs in the U.S. market over the last two decades. The expedited programs were created by the FDA as exceptions to the standard drug development and approval review process for drugs that were intended for an unmet medical need associated with treating life-threatening and serious conditions. During our study period, all new CRC drugs that were approved by the FDA were associated with at least one of these expedited programs.