FDA announced the creation of a voluntary pilot program that will assist clinicians in selecting the appropriate treatment for patients with cancer through the use of laboratory-developed tests, according to an FDA press release.
The new program pertains to “certain oncology drug products used with certain corresponding in vitro diagnostic tests,” according to the release.
Current FDA policy labels an in vitro companion diagnostic test as one that provides information essential for the safe and effective use of a corresponding treatment; certain limited circumstances allow for the agency to approve a life-saving treatment that requires the use of an in vitro companion diagnostic even if a corresponding in vitro companion diagnostic test has not yet received marketing authorization.
In such an event, tests offered as laboratory-developed tests have been used for patient treatment decisions.
According to the press release, the FDA has become concerned that lab-made tests the agency did not authorize may not provide accurate and reliable results, which can negatively impact treatment decisions.
The new pilot program seeks to assist in reducing the risk of using laboratory-developed tests for oncology drug treatment decisions while the FDA continues work on a broader approach for their use.
“We believe this guidance and the launch of the pilot program are important steps towards addressing safety risks posed by the use of poorly performing laboratory-developed tests,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a press release. “The pilot aims to help by making transparent performance recommendations for diagnostic tests used to select certain oncology drug treatments.”
The voluntary program will allow the FDA to request performance information for tests used to enroll patients into clinical trials from drug manufacturers, after which the FDA will post to its website the minimum performance characteristics recommended for similar tests to be used to select patients for treatment with the approved drug based on an assessment of the information received.
The initial phase of the pilot program is expected to last as long as 1 year, at which point the FDA will evaluate up to nine drug sponsors for possible acceptance into the pilot.
“Today’s pilot program launch, and corresponding guidance publication, is a step forward in improving cancer care for patients,” Richard Pazdur, MD, director of FDA’s Oncology Center of Excellence and acting director of the office of oncologic diseases in FDA’s Center for Drug Evaluation and Research, said in the release. “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.”