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

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 a
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SOURCE U.S. Food and Drug Administration
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