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FDA Cancer Drug Approval Rate Highlighted in JNCI
Date:2/18/2010

During the 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.

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 Five applications were not approved, and two applications were withdrawn before any regulatory action was taken. These 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, Ph.D., lead author of the FDA analysis.

"We also considered the patient populations in need of additional treatment options, existing treatments, and whether this was a new molecular entity," said Sridhara, an acting division director, in CDER's Office of Biostatistics.


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SOURCE U.S. Food and Drug Administration
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