FDA renames and restructures oncology office
The FDA’s office responsible for approving cancer therapies has been renamed the Office of Oncologic Diseases (OOD) and restructured to add new divisions, the agency announced Wednesday.
OOD, which was previously known as the Office of Hematology and Oncology Products (OHOP), will shift from three clinical divisions and one nonclinical division to six divisions, including three divisions of oncology:
- DO1, directed by Julia Beaver, will deal with products for breast, gynecologic and genitourinary cancers as well as supportive care;
- DO2, with acting director Harpreet Singh, will review products for thoracic and head and neck cancers, central nervous system cancers, pediatric solid tumors and rare cancers;
- DO3, with acting director Steven Lemery, will review products for gastrointestinal malignancies, melanoma and other advanced skin cancers and sarcomas.
The other new divisions will include the Division of Hematologic Malignancies 1 (DHM1), which will be led by acting director Angelo De Claro and 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 (BPDCN), conditioning regimens for DHM1 indications, graft versus host disease, tumor lysis syndrome, cytokine release syndrome and CAR-T neurotoxicity,” the FDA said.
And the Division of Hematologic Malignancies 2 (DHM2), led by acting director Nicole Gormley, will review products for lymphoma, chronic lymphocytic leukemia, multiple myeloma, and other plasma cell malignancies.
DHM1 and DHM2 were previously known as the Division of Hematology Products (DHP). And the FDA said the Division of Hematology Oncology Toxicology (DHOT), which is the nonclinical review division for oncology products led by director John Leighton, will remain the same.
“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),” the FDA said.
Richard Pazdur, director of OHOP since 2005, is the acting director of OOD.
“In addition, a centralized Safety Team has been created in the OOD to work with the review divisions to provide for consistent review, management, and communication of safety information across development programs and throughout the pre- and post-market life-cycle of oncology drugs. A centralized labeling team will standardize and harmonize labeling efforts across OOD,” the FDA said.
Regulatory staff supporting OOD will be in the newly created Division of Regulatory Operations – Oncologic Diseases (DRO-OD), with individual branches supporting each of the five clinical review divisions in OOD.
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