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FDA Cancer Drug Approval Rate Highlighted in JNCI

Agency Analysis: More than 50 new cancer indications approved over a 32-month period

SILVER SPRING, Md., Feb. 18 /PRNewswire-USNewswire/ -- The U.S. 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.

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 Five applications were not approved, and two applications were withdrawn before any regulatory action was taken.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

The FDA's retrospective analysis appears in the Feb. 24, 2010, issue of the Journal of the National Cancer Institute. The journal article is available now at

Approval data from July 1, 2005 through Dec. 31, 2007 were reviewed by the authors for this analysis. This review was started after the formation of the Office of Oncology Drug Products and the implementation in 2007 of the Food and Drug Administration Amendments Act (FDAAA). The review included indications for both conventional oncology drugs and biological oncology products reviewed in CDER. It did not include products reviewed in other FDA centers.

"The FDA used a variety of trial designs and endpoints in approving these applications. In addition, we implemented recent regulatory initiatives including accelerated approval and priority reviews to expedite the approval of these indications," said Richard Pazdur, M.D., director of the Office of Oncology Drug Products, and one of the review's co-authors.

The accelerated approval process allows for earlier approval of drugs to treat serious diseases with an unmet medical need and is based on a surrogate endpoint, a laboratory measurement or physical sign that is used in clinical trials as an indirect measurement of clinical benefit. Under an accelerated approval, the FDA approves the drug on the condition that the drug manufacturer conducts further studies to evaluate the drug's actual clinical benefit. Priority reviews are conducted within six months, whereas other reviews are usually reviewed in 10 months.

Other highlights from the cancer drug approvals review include:

  • New treatments were approved for six of the seven most deadly forms of cancer in the United States (lung, colon, breast, ovarian, cervical and pancreatic)
  • 35 of the approvals were existing products seeking new treatment indications
  • New molecular entities represented 18, or 34 percent, of the 53 approvals
  • Approvals included treatments for pediatric patients, supportive care indications aimed at improving the side effects of cancer therapies, and treatment options for rare diseases  
  • Three new treatments were approved for advanced kidney cancer
  • Nine drugs received accelerated approval, a regulatory mechanism allowing the FDA to approve a drug with subsequent studies performed after approval to demonstrate an effect on survival or other clinically meaningful endpoints
  • Twenty five percent of the indications approved were based on improvement in overall survival or improvement in both progression-free survival and overall survival

Other authors of the review include: John R. Johnson, M.D., Clinical Team Leader, Robert Justice, M.D., director of the Division of Drug Oncology Products, Patricia Keegan, M.D., director of the Division of Biologic Oncology Products and Aloka Chakravarty, Ph.D., acting division director, Division of Biometrics VII, Office of Biostatistics.

For more information:

FDA Office of Oncology Drug Products

Food and Drug Administration Amendments Act (FDAAA)

Journal of the National Cancer Institute

Media Inquiries: Erica Jefferson, 301-796-4988,

Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration

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SOURCE U.S. Food and Drug Administration
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