FDA restructures, renames office that reviews cancer therapies
The FDA office that reviews applications for cancer therapies has been renamed and reorganized.
The Center for Drug Evaluation and Research’s Office of Oncologic Diseases — formerly known as the Office of Hematology and Oncology Products — now is structured under terms of a modernization plan approved last fall.
Richard Pazdur, MD — who served as director of the Office of Hematology and Oncology Products since 2005 — will serve as acting director of the reorganized entity.
“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 in an FDA-issued press release. “Reorganizing the office in this manner will allow for greater stakeholder engagement in the various disease programs.”
The old structure consisted of three clinical divisions and one nonclinical division.
The new structure includes six divisions.
• Division of Oncology 1 will be responsible for breast, gynecologic and genitourinary cancers, as well as supportive care.
• Division of Oncology 2 will review products for head and neck cancers, thoracic cancers, central nervous system cancers, pediatric solid tumors and rare cancers.
• Division of Oncology 3 will review products for melanoma and other skin cancers, gastrointestinal cancers and sarcomas.
• Division of Hematologic Malignancies 1 will be responsible for products for acute leukemia and myelodysplasia, chronic myeloid leukemia and other myeloproliferative neoplasms with the term “leukemia,” and blastic plasmacytoid dendritic cell neoplasm; conditioning regimens for these indications; graft-versus-host disease, cytokine release syndrome, tumor lysis syndrome and chimeric antigen receptor T-cell therapy neurotoxicity.
• Division of Hematologic Malignancies 2 will review products for lymphoma, chronic lymphocytic leukemia, multiple myeloma and other plasma cell malignancies.
• Division of Hematology Oncology Toxicology remains unchanged.
The newly formed Division of Non-malignant Hematology — part of the Office of Cardiology, Hematology, Endocrinology and Nephrology — will review products for benign hematologic diseases and other conditions.