FDA Cancer Drug Approval Rate Highlighted in JNCI

The US Food and Drug Administration’s Office of Oncology Drug Products approved more than 50 new indications for the use of oncology and hematology drugs and biologics between July 2005, when the office began reviewing marketing applications, and the end of 2007, according to a new agency study.

During this time period, the office reviewed 60 applications from companies seeking approval to treat people with 30 different types of cancer, including breast, lung, colon, kidney, head and neck, and several forms of blood cancer.

New Drugs, Expanded Indications

The Office of Oncology Drug Products, part of the Center for Drug Evaluation and Research (CDER), took action on 58 of the applications, approving 53 new cancer indications. Five applications were not approved, and two applications were withdrawn before any regulatory action was taken. The approved applications included indications for 18 new drugs that had not been previously approved and 35 additional indications for already approved drugs.

“Our reviews during this period focused on approving new or existing treatments based on treatment effect, patient safety, and the treatment’s risk-benefit profile,” said Rajeshwari Sridhara, PhD, lead author of the analysis. “We also considered the patient populations in need of additional treatment options, existing treatments, and whether this was a new molecular entity,” said Dr. Sridhara, acting division director in CDER’s Office of Biostatistics.

The retrospective analysis appeared in the February 24, 2010, issue of the Journal of the National Cancer Institute.