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YOUR GO-TO SOURCE FOR ANALYSIS OF ISSUES AFFECTING THE PHARMA & BIOTECH SECTORS

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.

Office of Oncologic Diseases

Division of Oncology 1

Responsible for products for breast, gynecologic, and genitourinary cancers as well as supportive care.

Division of Oncology 2

Responsible for products for thoracic and head and neck cancers, central nervous system cancers, pediatric solid tumors, and rare cancers.

Division of Oncology 3

Responsible for products for gastrointestinal malignancies, melanoma and other advanced skin cancers, and sarcomas.

Division of Hematologic Malignancies 1

Responsible for products for acute leukemia and myelodysplasia (myelodysplastic-myeloproliferative overlap syndromes), chronic myeloid leukemia and other myeloproliferative neoplasms with the term “leukemia,” blastic plasmacytoid dendritic cell neoplasm, conditioning regimens for other division indications, graft versus host disease, tumor lysis syndrome, cytokine release syndrome, and CAR-T neurotoxicity.

Division of Hematologic Malignancies 2

Responsible for products for lymphoma, chronic lymphocytic leukemia, multiple myeloma, and other plasma cell malignancies.

Division of Hematology and Oncology Toxicology

Responsible for the nonclinical toxicology and pharmacology review for oncology products.


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.

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.

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.