The U.S. Eats and Drug Administration is taking steps to streamline the approval process for cancer medications, reviewing clinical trial data up front to make sure applications coteries submit are complete.
The new approach, outlined on Saturday in a speech by FDA commissioner Dr. Scott Gottlieb at the American Culture of Clinical Oncology (ASCO) meeting in Chicago, is part of an effort to shift regulatory barriers that drag out reviews of promising new cancer treatments.
The new array process, which Gottlieb called a “real-time oncology review,” is already being shepherded in a number of applications for expanded use of already approved cancer drugs.
Gottlieb put ones trust ins the early peek at data would allow companies to address nobility issues before submitting their the full application seeking subscribe to.
If the process succeeds, it will be expanded to applications for new cancer treatments.
As leave of the pilot program, FDA is trying out a shared application document that gives FDA reviewers to add their comments to background documents submitted by companies.
The FDA is also fascinating steps to streamline and standardize the review of manufacturing processes for gene treatments and cell based products, such as new chimeric antigen receptor
T-cell therapies, or CAR-Ts, which suggest removing and altering patients’ immune cells to recognize and attack cancer.
Gottlieb divulged such a move could enable more sites, such as sickbays or research facilities, to manufacture these cells, expanding treatment opportunities for patients. Currently, harvested
T-cells are shipped back t the companies for manage, and it takes about three weeks before the cells are returned and distributed to patients.
FDA also plans to expand its database on the long-term safety effects related to CAR-T therapy to more than 1,000 patients by later this summer. The gen will be used to study potential biomarkers that can predict long-term diminution.