As part of the US Food and Drug Administration’s (FDA’s) overall reorganization of the Office of New Drugs, the former Office of Hematology and Oncology Products (OHOP), the FDA office responsible for approving cancer therapies, was recently restructured and renamed the Office of Oncologic Diseases (OOD).
Per Dr. Richard Pazdur, the acting OOD director, the reorganization will allow for greater stakeholder engagement and streamline the drug review process. OOD is now composed of six divisions, including three divisions of oncology.
This reorganization may impact investigational and marketing applications in a number of ways. For example, if an IND is submitted to FDA that contains multiple protocols or if new protocols are submitted for indications/diseases that are unrelated to an existing IND, even if the applications are submitted to the same review division, separate INDs may be needed so that the application can be reviewed by the appropriate OOD team. FDA also advises that sponsors intending to conduct trials with multiple expansion cohorts meet with the agency before making a submission to determine whether a new IND is needed. For pending marketing applications, FDA states that, while review teams will not change, FDA’s responsible division and signatory may change. Sponsors will be notified if there is a change in FDA signatory, responsible division, or point of contact for applications currently under review.The management and processing of Investigational New Drug (IND) and marketing applications, including submissions and meeting requests, will now be handled by the Division of Regulatory Operations – Oncologic Diseases, under the Office of Regulatory Operations, within the Office of New Drugs. OOD has also outlined general principles regarding submissions to the division, which all sponsors in the oncology space should closely review. To understand if an application may be affected by the reorganization, sponsors should additionally review FDA’s posted file of applications affected by the reorganization.
Despite these changes, however, and according to recent remarks from Dr. Peter Stein, the director of the Office of New Drugs, FDA is trying to ensure consistency between prior and new review teams. Thus, at least at this point, while sponsors may find themselves interacting with new people within a review division, FDA’s prior comments and advice with respect to particular development programs should materially remain the same.