FDA’s Office of Hematology and Oncology Products Reorganizes

By Trevan Locke, PhD

Earlier this month, the U.S. Food and Drug Administration (FDA) announced that the Office of Hematology and Oncology Products (OHOP), which is responsible for reviewing cancer therapies, has been reorganized into the Office of Oncologic Diseases (OOD) as part of a broader effort within the Center for Drug Evaluation and Research to modernize its New Drugs Regulatory Program.

Richard Pazdur, MD, director of the Oncology Center of Excellence (OCE) at the FDA, is the acting director of the newly reorganized OOD. The OCE, established in 2017 to help expedite the development of oncology therapies, will not be affected by this reorganization.

As the practice of oncology and the treatments for these life-threatening diseases have become more complex, we recognized the need to flatten the organization with additional but smaller review divisions to enable more efficient drug review,” Pazdur said. “Reorganizing the office in this manner will allow for greater stakeholder engagement in the various disease programs.”

Previously, OHOP was made up of three clinical divisions and one nonclinical division: Division of Oncology Products 1 (DOP1), Division of Oncology Products 2 (DOP2), Division of Hematology Products (DHP), and Division of Hematology Oncology Toxicology (DHOT).

The new OOD structure comprises six divisions:

• Division of Oncology 1 (DO1), formerly DOP1, will continue its focus on products for breast, gynecologic, and genitourinary cancers as well as supportive care and remains under the direction of Julia Beaver, MD.
• Division of Oncology 2 (DO2), led by Acting Division Director Harpreet Singh, MD, will review products intended to treat thoracic and head and neck cancers, central nervous system cancers, pediatric solid tumors, and rare cancers.
• Division of Oncology 3 (DO3), led by Acting Division Director Stephen Lemery, MD, will review products for gastrointestinal malignancies, melanoma and other advanced skin cancers, and sarcomas.
• Division of Hematologic Malignancies 1 (DHM1) will be responsible for products for acute leukemia and myelodysplasia (includes myelodysplastic-myeloproliferative overlap syndromes), chronic myeloid leukemia and other myeloproliferative neoplasms with the term “leukemia,” blastic plasmacytoid dendritic cell neoplasm, conditioning regimens for DHM1 indications, graft versus host disease, tumor lysis syndrome, cytokine release syndrome, and CAR-T neurotoxicity. Angelo de Claro, MD, has been named acting division director of this division.
• Division of Hematologic Malignancies 2 (DHM2), with Nicole Gormley, MD, serving as acting division director, will focus on products for lymphoma, chronic lymphocytic leukemia, multiple myeloma, and other plasma cell malignancies. Products for non-malignant hematologic diseases and conditions that DHP previously covered will be reviewed in the newly formed Division of Non-malignant Hematology in the Office of Cardiology, Hematology, Endocrinology and Nephrology.
• Division of Hematology Oncology Toxicology, led by John Leighton, PhD, remains the same, and will continue to review nonclinical pharmacology and toxicology aspects of cancer therapies.

Regulatory project management staff supporting OOD will be in the newly formed Division of Regulatory Operations – Oncologic Diseases, with individual branches supporting each of the five clinical review divisions in OOD.

In addition, a new, centralized safety team will provide consistency in the review and communication of safety information across development programs and throughout the lifecycle of cancer therapies. A centralized labeling team will coordinate labeling efforts across OOD.

The OOD reorganization is part of a broader modernization effort at the Center for Drug Evaluation and Research. As part of this process, the Office of New Drugs (OND), of which OOD is a part, is also creating offices that align with disease areas and divisions within those offices. The OND will expand the number of clinical review divisions from 19 to 27. These new divisions, based on disease expertise, are expected to help the agency better understand the diseases that the drugs they review are intended to treat. The newly reorganized clinical review divisions will be supported by six non-clinical divisions.

For more information about the OOD reorganization, visit the FDA website.