FDA Establishes Office of Oncologic Diseases to Streamline Drug Review Process

Nov. 8, 2019 – The FDA announced this week that it has reorganized its office that reviews applications for new and existing cancer therapies; its Office of Hematology Oncology Products has been renamed the Office of Oncologic Diseases (OOD) and has six divisions to accommodate a more streamlined drug review process, according to a Nov. 5 FDA statement.

“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,” said OOD Acting Director Richard Pazdur, M.D. “Reorganizing the office in this manner will allow for greater stakeholder engagement in the various disease programs,” he said.

This move is part of an FDA modernization plan set in motion in September. “Establishment of this new Office of Oncologic Diseases is an important component of the larger reorganization, put in process by former FDA Commissioner Dr. Scott Gottlieb, to make the FDA’s drug review and approval process more efficient,” explained Coalition for Healthcare Communication Jon Bigelow.

Specifically, the new OOD structure consists of the following divisions:

  • Division of Oncologic Products (DOP) 1 is re-named Division of Oncology 1 (DO1).
  • DOP2 will be split into two divisions: Division of Oncology 2 (DO2) and Division of Oncology 3 (DO3).
  • Division of Hematology Products (DHP) will be split into two divisions to review products intended to treat hematologic malignancies: Division of Hematologic Malignancies 1 (DHM1) and Division of Hematologic Malignancies 2 (DHM2). DHP’s review of products to treat non-malignant hematologic conditions will move to another office within CDER.
  • Division of Hematology Oncology Toxicology remains the same.

DO1 will retain its responsibilities for products for breast, gynecologic, and genitourinary cancers as well as supportive care.

DO2 will review products for thoracic and head and neck cancers, central nervous system cancers, pediatric solid tumors, and rare cancers.

DO3 will review products for gastrointestinal malignancies, melanoma and other advanced skin cancers, and sarcomas.

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 (BPDCN), conditioning regimens for DHM1 indications, graft versus host disease, tumor lysis syndrome, cytokine release syndrome, and CAR-T neurotoxicity.

DHM2 will review for 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 (DNH) in the Office of Cardiology, Hematology, Endocrinology and Nephrology (OCHEN).

The FDA modernization plan has four phases; this reorganization is part of the second phase.