More than 50 new cancer indications approved by USA's FDA over a 32-month period

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 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 Five applications were not approved, and two were withdrawn before any regulatory action was taken.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.