FDA to Review Lung Cancer Drug Iressa's Effectiveness Amid Concerns Over Fast-Track Approval Process

Strategic Insights -

Liz Szabo writes that an FDA advisory panel will review recent research showing that the lung cancer drug Iressa, which received fast-track approval two years ago, fails to improve survival. The drug, approved in 2003, was given accelerated approval on the condition that its maker conduct additional studies to confirm its benefits. Despite this, a study of nearly 1,700 patients showed that those who took Iressa lived no longer than those who took placebos.

Key Takeaways:

  • Iressa, a lung cancer drug, received fast-track approval in 2003 on the condition that its maker conduct additional studies to confirm its benefits.
  • A study of nearly 1,700 patients showed that those who took Iressa lived no longer than those who took placebos.
  • Researchers discovered that patients who had tumors that responded to Iressa tend to share a common genetic profile, leading scientists to talk of a new era of customized cancer care.
  • The discovery of a genetic profile that responds to Iressa may lead to the development of drugs that can be prescribed based on a patient's DNA.
  • The FDA has been under fire for approving drugs that were later found to pose health risks, but the American Cancer Society's Len Lichtenfeld says the FDA was right to approve Iressa.
  • Some patients with advanced cancer who have taken Iressa have lived for years, while others have experienced dramatic recoveries.
  • The FDA has been promoting a similar drug, called Tarceva, which was given fast-track approval in November after tests showed that it prolongs life for those in advanced stages of disease.

Statistics:

  • 10% of patients showed improvement in tests on Iressa
  • 1,700 patients were studied in the clinical trial
  • 2 years the time period between Iressa's approval and recent review
  • FDA's fast-track program was created to speed promising drugs to patients with life-threatening illnesses
  • AstraZeneca, the manufacturer of Iressa, no longer promotes the drug
  • Tarceva, a similar drug, was given fast-track approval in November

Sources:

  • AstraZeneca spokeswoman Mary Lynn Carver
  • American Cancer Society's Len Lichtenfeld
  • Source: "FDA Advisory Panel to Review Lung Cancer Drug Iressa's Effectiveness". Contact: Liz Szabo