Drug companies developing cancer treatments can fold the risk assessment of unapproved screening tests into their clinical trial application instead of filing separately.
The final guidance from the Food and Drug Administration marks another step to advance precision medicine, an emerging approach for disease prevention and treatment that targets care based on an individual’s genes, environment, and lifestyle. A linchpin of precision medicine is a diagnostic that determines if a patient will benefit from a treatment.
Cancer therapies in particular have benefited from advances in precision medicine, such as treatments like Roche’s Rozlytrek and Bayer’s Vitrakvi that target genetic drivers linked to certain cancers instead of the body part where the cancer originated.
Devices deemed to pose a significant risk to patients require approval of an investigational device exemption before they can be used in a clinical study. If a drug company is working on a cancer therapy with an unapproved diagnostic, it typically has to submit separate applications for the investigational drug and the unapproved in vitro diagnostic, according to the American Society of Clinical Oncology.
The final guidance released Oct. 9 allows the drug company to include all that information into a single package that goes to the FDA. The directive comes the same day President Donald Trump is expected to sign a pair of executive orders limiting federal agencies’ ability to issue nonbinding guidance rather than going through the longer regulatory process.
Under the guidance, all the information about the in vitro diagnostic would now be included in the investigational new drug application. It’s at that point that the FDA would determine whether the in vitro diagnostic poses a risk that’s significant, non-significant, or if it can be exempted from the investigational device exemption requirements.
A significant-risk device will still need an exemption, but the agency said it’s a way to reduce red tape for drug companies without compromising standards on safety.