Overview of Oncology and Hematology Drug Approvals at US Food and Drug Administration Between 2008 and 2016
Methods: All oncology–hematology applications submitted to the FDA from January 1, 2008, through December 31, 2016, were identified and their approval actions reviewed.
- The Office of Hematology and Oncology Products approved 239 applications supporting 260 new indications.
- 141 applications were approved via priority review and 98 via standard review.
- 53 applications were granted accelerated approval, 29 were converted from accelerated to regular approval, and 157 received regular approval.
- Since 2013, breakthrough designation status was granted to 25.7% of applications.
- A variety of endpoints were used to support these approvals.
We previously reviewed the oncology products approved by the FDA between July 2005 and December 2007 (1). Since 2007, however, a number of changes have taken place to accommodate a dramatic increase in applications in oncology. The Office of Oncology Drug Products (OODP), created in July 2005 to oversee new drug applications and biologic licensing applications for oncological and hematological products, contained three divisions to accommodate the review of oncology products: Division of Drug Oncology Products, Division of Biologic Oncology Products, and Division of Medical Imaging and Hematology Products.
In 2011, OODP was reorganized and renamed the Office of Hematology and Oncology Products (OHOP) based on disease-specific therapeutic areas and organized into four different divisions: Division of Oncology Products 1, Division of Oncology Products 2, Division of Hematology Products, and Division of Hematology Oncology Toxicology. This reorganization was intended to standardize and expedite the process of reviewing applications in oncology and hematology drug products...
Click for Source
