Today, the U.S. Food and Drug Administration (FDA) announced the availability of the draft guidance titled
“Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biologic Products for Treatment.” The purpose of this guidance is to help applicants planning to use minimal residual disease (MRD) as a biomarker in clinical trials conducted under an Investigational New Drug Application (IND) to support marketing approval of drugs and biological products for the treatment of specific hematological malignancies. This guidance specifically describes for applicants the development of MRD as a biomarker for regulatory use, technology considerations including assay considerations and sampling considerations, disease specific considerations, and regulatory submissions which utilize MRD.
MRD is a measure of disease burden in leukemia and other hematologic cancers. Conventional detection techniques were not able to detect MRD, however newer technologies that can measure cell characteristics such as genetic mutations or cell surface markers are able to detect MRD. MRD as a measure of tumor burden has multiple potential regulatory and clinical uses as a biomarker. Along with this, there are many challenges that come with using MRD as a biomarker in clinical trials. Based on these challenges, FDA identified a need to provide sponsors with guidance on use of MRD as a biomarker in regulatory submissions.
FDA encourages applicants to meet with the Agency before starting a drug development pathway incorporating MRD assessment intended to support NDA and BLA marketing applications.
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