A new FDA pilot program would pre-review sponsors’ data submissions to reduce delays in oncology drug development.
The pilot will target efficacy supplements for currently-approved cancer drugs, but the agency may broaden the program to drugs and biologics currently under consideration for final approval.
Under a “real-time oncology review,” the agency would review clinical trial data up front to ensure applications are complete, FDA Commissioner Scott Gottlieb said at the American Society of Clinical Oncology’s annual meeting in Chicago, noting that drug sponsors finding that application data are incomplete after the fact is a major contributor to development delays and increased costs.
The pre-review would begin two to four weeks after the sponsor has locked its database, with the FDA reviewing raw and derived datasets and safety and efficacy data. The pilot will include a shared application document in which FDA reviewers can add comments to sponsors’ background data.