OCE at Three: Looking Back and Forward to 2025
As the US Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE) enters its third year in operation, the center held a public workshop on Wednesday to review the projects that it has undertaken and will explore the future.In addition to approving dozens of new oncology drugs and diagnostic tests, OCE, which was created with funding from the 21st Century Cures Act, has established pilot projects to speed new drug approvals, work alongside other regulators to approve new treatments or indications in tandem, update cancer drug labels more quickly and better help physicians complete expanded access requests for cancer patients.
On the expanded access requests, several panelists at the workshop said they thought FDA should work with companies more closely to try to approve such requests, even if the treatment is already approved. OCE Director Rick Pazdur explained how some at FDA do not support expanded access for approved drugs in unapproved indications, but it has occurred in the past.
“It’s very little work on our part to review an expanded access request – if it’s the right thing from a patient perspective, let the regulatory framework not be the obstacle,” Pazdur said.
OCE also has established Project Protect, which will allow IND safety reports to be submitted in a standard electronic format (via ICH E2B) to allow for more effective review and tracking of safety information, and Project Socrates, which aims to build an educational network bridging oncology drug development and regulatory policy and science from FDA to the public.
One new project was also discussed, known as Project Patient Voice, which will be like a drug trials snapshot but for patient experience information. A workshop on the new project will be held 17 July.
“When I first arrived at the FDA in 1999, the agency had 10 medical oncologists who each reviewed drugs for all types of cancer. We now have more than 100 medical and hematologic oncologists who specialize in specific cancers and develop deep expertise through their review work, professional development, and research interests,” Pazdur added in the new annual report.
Much of Wednesday’s discussions focused on what OCE has done with these various projects and how the center can be more patient-focused, as well as what is coming down the pike legislatively.
Two staff members from Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) said work has begun on the next iteration of the Cures Act, to be known as Cures 2.0. They said they’re looking to take a similarly bipartisan approach in developing the next bill, which may focus less on the discovery and development of new treatments and more on the delivery of those treatments to more patients.
Upton’s staffer said he thought the bill could target work between FDA and the Centers for Medicare and Medicaid Services on horizon scanning to see what treatments may be approved and to speed the coverage process.
OCE Annual Report