Drugs

Oncology Drug Pilot on LDT Performance Criteria

While FDA continues to pursue a new regulatory paradigm for laboratory-developed tests (LDTs), the agency is starting a new pilot program to add more regulatory teeth to LDTs that are used without an approved companion diagnostic for certain oncology drugs. Speaking at a Friends of Cancer Research (FOCR) public meeting 7/11 (see video), Oncology Center of Excellence (OCE) associate director Harpreet Singh announced the new pilot to reduce the risk of using individual LDTs to qualify patients for new oncology drugs when a companion diagnostic is not approved.

Singh told FOCR that over the past 10 years, there have been about 40 oncologic drugs approved without an approved companion diagnostic. “We do this when we believe the benefits of making this drug available to patients outweigh the risk of approving absent a one singular companion diagnostic,” she said. In these situations, Singh said, patients are selected for approved drugs based on unregulated LDTs despite OCE’s suspicion that the patients “are being potentially subjected to tests which may not actually be properly identifying them.”

The pilot was announced last month in a guidance, Singh told FOCR. “This pilot program is one step that may be helpful in reducing the risk of using LDTs for oncology drug treatment decisions while we continue to work on a broader approach for LDTs, including moving forward with rulemaking,” the guidance says.

Under the pilot, FDA will prospectively ask drug manufacturers during their meetings to discuss pivotal trials for performance information for the tests used to enroll patients into clinical trials that support drug approval. “Based on an assessment of that information,” the guidance says, “FDA will post to the FDA Web site the minimum performance characteristics recommended for similar tests that may be used to select patients for treatment with the approved drug. Laboratories may use this information to guide their development of LDTs to identify specific biomarkers used for selecting cancer treatment. This transparency aims to help facilitate better and more consistent performance of these tests, resulting in better drug selection and approved care for patients with cancer.”

Session moderator and OCE director Rick Pazdur said that if successful, the pilot could eliminate the “bridging that has to happen between what was used in the clinical trial versus what an approved test would be.” However, he emphasized that the performance criteria do not preclude a company from seeking an approved companion diagnostic, adding that “we would expect that there would be an interest in some of these approved tests being done.”

The initial phase of the pilot is expected to last up to one year, FDA says, during which the agency will evaluate no more than nine drug sponsors for possible acceptance into the program.

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