FDA Proposes Guidelines for Diagnostic Drug Tests

Administration of personalized diagnostic tests—so-called targeted treatments and companion diagnostics—might soon have stricter mandates and procedures under proposed U.S. Food and Drug Administration (FDA) guidelines.

The agency issued the draft guidelines to help in the creation and review of these tests, which are used to determine if patients with specific diseases or conditions should undergo certain drug treatments, said Digital Journal.

The proposed rules would require that the personalized treatment only receive approval if the collaborating diagnostic device is approved, as well. The only exceptions are if the treatment is needed for serious of life-threatening conditions, noted Reuters, that have no appropriate alternatives and if “pronounced” benefits outweigh risks, and if the change is to labeling of an approved therapy and that change deals with safety issues.

Reuters explained that these targeted drugs and therapies would, under the FDA proposal, mandate review with the diagnostic devices with which they work, noting that these “targeted treatments” and “personalized medicines” are unique to a patient’s genetics. Development of these treatments and tests continues to increase, noted Reuters.

The companion diagnostics are meant to improve targeted treatment efficacy by helping health care professionals determine a patient’s genetic match with the therapy mandated, said Reuters. In other words. The diagnostics better enable physicians to figure out which patients will best benefit from an emerging drug and which patients could be in danger from that drug, noted Reuters.

One of the more popular targeted treatments determines if a patient has a “specific gene amplification or protein over-expression” and could determine if a medication might help or harm the patient, Reuters said, using the 1998 FDA-approved breast cancer drug, Herceptin (trastuzumab), as an example. Herceptin targets HER2 gene amplification or protein over-expression and was approved with a companion test that is generally administered on women who have breast cancer. The test helps health care professionals working with breast cancer patients determine if those patients are good candidates for Herceptin treatment, said Reuters.

“These proposed guidelines support the development of innovative new targeted medicines and their corresponding diagnostic tests and are intended to provide manufacturers with greater predictability,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, quoted Digital Journal. “It is the agency’s goal to help stimulate early collaborations between drug and device makers so they can develop the best medical products for treating patients,” Dr. Shuren added.

Another treatment, said Reuters, is Pfizer’s crizotinib, an experimental drug that seeks out a specific gene mutation common in nonsmokers with nonsmall cell lung cancer. The drug has a companion test created by Abbott Laboratories.

The draft guidance clarifies what the FDA defines as a companion diagnostic, recommends early collaboration between the agency and the drug maker, points out that the FDA will conduct simultaneous drug/biologic therapy and related corresponding companion diagnostic review, and identifies when the FDA might approved targeted treatments when no approved companion diagnostic exists, said Digital Journal.

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