The U.S. Food and Drug Administration (FDA) division that handles new and existing oncology drugs was renamed and restructured. The agency’s Center for Drug Evaluation and Research (CDER) Office of Hematology and Oncology Products (OHOP) is now the CDER’s Office of Oncologic Diseases (OOD).
“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,” said Richard Pazdur, acting director of OOD. He was the director of OHOP since 2005. “Reorganizing the office in this manner will allow for greater stakeholder engagement in the various disease programs.”
The division previously had three clinical divisions and one nonclinical division. Under the restructuring, it will six divisions, three for oncology. They are:
DO1, which will be run by Julia Beaver, and focus on products for breast, gynecologic and genitourinary cancer and supportive care.
DO2, with acting director Harpreet Singh. This division will review thoracic and head and neck cancer products, central nervous system cancers, pediatric solid tumors and rare cancers.
DO3, with acting director Steven Lemery. DO3 will oversee products for gastrointestinal cancers, melanoma and other advanced skin cancers and sarcomas.
Additional divisions will include the Division of Hematologic Malignancies 1 (DHM1), led by acting director Angelo De Claro. This will review 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 (BPDCN), conditioning regimens for DHM1 indications, graft versus host disease, tumor lysis syndrome, cytokine release syndrome and CAR-T neurotoxicity.”
DHM2 is the Division of Hematologic Malignancies 2, led by acting director Nicole Gormley. It will oversee lymphoma, chronic lymphocytic leukemia, multiple myeloma, and other plasma cell malignancies.
DHM1 and DHM2 were formerly the Division of Hematology Products (DHP).
The nonclinical review division for oncology products is the Division of Hematology Oncology Toxicology (DHOT), which will be run by John Leighton. It is staying the same.
The FDA indicated that, “Products for non-malignant hematologic diseases and conditions that DHP previously covered will be reviewed in the newly formed Division of Non-malignant Hematology (DNH) in the Office of Cardiology, Hematology, Endocrinology and Nephrology (OCHEN).”
A centralized Safety Team has been formed in the OOD to provide consistent review, management and communication with all the review divisions.
A newly formed Division of Regulatory Operations – Oncologic Diseases (DRO-OD) will support the OOD, with individual offices supporting the five clinical review divisions.
The Trump administration recently nominated a leading cancer expert to the position of commissioner of the FDA. It was announced this week that Stephen Hahn, chief medical executive of the University of Texas MD Anderson Cancer Center had been put forth as the top nominee as a permanent replacement for Commissioner Scott Gottlieb, who retired earlier this year. Ned Sharpless has been the acting commissioner since Gottlieb stepped down. Hahn is a radiation oncologist. Sharpless has returned to his position at the National Cancer Institute. Until Hahn is confirmed by the Senate, Admiral Brett Giroir, assistant secretary for health in the Department of Health and Human Services, will lead the agency.