FDA unveils changes to cancer drug review
pharmafile | September 14, 2011 | News story | Research and Development, Sales and Marketing | Cancer, FDA, regulatory affairs
The FDA has unveiled a reorganisation of how it reviews new cancer drugs, and says the new approach should help it maker better informed – and possibly faster – decisions.
The Center for Drug Evaluation and Research’s (CDER) Office of Oncology Drug Products has been reorganised and renamed the Office of Hematology and Oncology Products (OHOP).
The new system creates four separate drug review units, aimed at increasing the level of expertise in the department. Two units, DOP1 and DOP2, will each focus on a short list of specific solid tumours; meanwhile DHP will handle haematological tumours, and the new DHOT will review non-clinical pharmacology and toxicology aspects of cancer therapies.
Head of the department Dr Richard Pazdur said: “As the practice of oncology and the treatments being developed for these diseases have become more complex, we’ve recognised the need and importance of taking a more disease-specific review approach to these therapies”
He added that the reorganisation also aligns the FDA with the organisational structure of leading cancer treatment centres, academic programmes and the National Cancer Institute.
The new approach replaces a system in which small molecule drugs were assessed separately to biologics.
“Under the new office structure, the agency anticipates greater clarity and more transparent interactions with companies about the requirements to bring cancer treatments to market,” said CDER director Janet Woodcock.
Woodcock stopped short of saying decisions could be made quicker, but the FDA has made it clear it wants to speed up decisions wherever safe and practicable.
“We don’t expect these changes to slow down pending applications, in fact, we expect to see greater efficiencies that will better support our work to get cancer treatments to patients.”
The previous structure contained three divisions: Division of Hematology Products (DHP), Division of Drug Oncology Products (DDOP), and Division of Biologic Oncology Products (DBOP).
The new structure contains four divisions: Division of Hematology Products (DHP), Division of Oncology Products 1 (DOP1), Division of Oncology Products 2 (DOP2), and Division of Hematology Oncology Toxicology (DHOT).
New OHOP Structure and Division Therapeutic Areas
|
DOP1 |
DOP2 |
DHP |
DHOT |
|
Division Director |
Division Director |
Division Director |
Division Director |
|
Breast, Gynaecologic, Genitourinary, Supportive care (non-hematologic) |
Gastrointestinal, Lung/Head & Neck, Neuro-oncology/Rare cancers/Paediatric Solid Tumour, Melanoma/Sarcoma |
Benign haematology, Haematologic malignancies, Haematology support, Paediatric Haematology |
Nonclinical Review Division for Haematology/Oncology products |
OHOP at-a-glance (source: FDA)
130: total employees in OHOP
55: number of medical oncologists in OHOP
39: number of pharmacists, nurses and non-clinical Ph.D.s in OHOP
19: Number of medical oncologists, nurses and pharmacists still treating patients
24: OHOP staff published in 2010
10: number of new drug indications approved in 2010
7: number of new molecular entities approved to date in 2011
Andrew McConaghie
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