The Food and Drug Administration has launched a pilot program for oncology drug products used with certain in vitro diagnostic tests to help physicians choose appropriate cancer treatments, according to the FDA Tuesday.
The voluntary pilot program will allow the FDA to request performance information for the tests used to enroll patients into the clinical trials that support drug approval, said the agency. The FDA will then post to its website the minimum performance characteristics recommended for similar tests that may be used to select patients for treatment with the approved drug.
Laboratories will then be able to use this information to steer their development of laboratory developed tests (LDTs) to identify specific biomarkers used for selecting cancer treatment, said FDA. The first phase of the program is expected to last up to a year. The FDA will evaluate up to nine drug sponsors for potential acceptance.
The program is part of the FDA’s effort to reduce the risk of using LDTs for oncology treatment decisions, including tests that have not yet received marketing authorization. This comes as the FDA moves ahead with plans to give itself explicit authority over medical tests that come from a single laboratory.
“This pilot program demonstrates the FDA’s commitment to collaborating with the pharmaceutical industry and other key stakeholders to address concerns and questions around the use of unauthorized diagnostics,” Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, said in a statement.
The FDA intends to propose a rule on LDTs by August, according to a notice included in the June 13 unified agenda, a list of the US government’s expected regulatory actions published twice a year. The agency promised to move forward with regulation on LDTs after Congress failed to pass measures last year that would have established a new medical product category for in vitro clinical tests.
Action in this area would settle a longstanding debate over whether FDA can regulate in vitro diagnostics created in a single laboratory the same way it has regulated commercial diagnostics. The FDA has always defended its ability to do so, but lab groups and academic medical centers have repeatedly pushed back, arguing that they already follow laboratory requirements from the Centers for Medicare & Medicaid Services.
Oncology drug product sponsors may be eligible for the new pilot program if they agree “to discuss with FDAanalytical validation data and performance characteristics for clinical trial assays prior to enrollment of the pivotal clinical trial,” and if the clinical study protocols “use tests that have specified performance characteristics recommended by FDA for acceptance into the pilot,” according to the FDA program guidance.
“We support the new FDA Pilot Program’s goals of ensuring high-quality test performance, transparency, and maximizing patient access to accurate tests needed to inform treatment decisions,” Jeff Allen, president and CEO of Friends of Cancer Research, said in an email.
“Beyond the scope of this voluntary pilot, we urge Congress to continue their work to provide FDA the tools to more broadly ensure test accuracy for patients,” Allen said.
