Goal of New FDA Pilot Project is Better Matching of Patients to Oncology Drugs

The FDA has begun a pilot project for CDER-regulated oncology drugs and the corresponding clinical assays to better understand the performance of the in vitro diagnostic tests used to identify the right treatment for cancer patients.

The FDA says the pilot is intended to support “better and more consistent performance of certain laboratory developed tests” used for making patient treatment decisions focusing on “performance characteristics that certain tests for oncology biomarkers should meet.”

Without altering the standards for approval of the oncology drug products or for marketing authorization of the corresponding companion test, the FDA says the pilot is intended to result “in better drug selection and improved care for patients with cancer ... by providing transparency regarding minimum performance necessary for in vitro diagnostic tests used with oncology drug products.”

For drugs enrolled in this pilot program, the agency said it expects that at the time of drug product approval, the agency will recommend “minimum performance characteristics for in vitro diagnostic tests to be used to identify patients for treatment with that drug product.”

Enrollment in the pilot began June 20.

Read the final guidance for the pilot project here.

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