FDA Advisory Committee Votes Against Approval of Tarceva for Advanced Lung Cancer

Strategic Insights -

The US Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC) has voted 12 to 1 against recommending approval of Tarceva (erlotinib) for first-line maintenance use in advanced or metastatic non-small cell lung cancer (NSCLC) patients whose cancer has not progressed after platinum-based chemotherapy. This decision was based on a review of data from the pivotal Phase III SATURN study, which showed a statistically significant improvement in both progression-free survival (PFS) and overall survival (OS) with Tarceva compared to placebo in the NSCLC maintenance setting. The FDA is expected to make a decision on Tarceva's approval by 18 January 2010.

Key Takeaways:

  • The ODAC voted 12 to 1 against recommending approval of Tarceva for first-line maintenance use in advanced or metastatic NSCLC.
  • The decision was based on a review of data from the pivotal Phase III SATURN study.
  • The study showed a statistically significant improvement in both PFS and OS with Tarceva compared to placebo in the NSCLC maintenance setting.
  • There were no new or unexpected safety signals in the study, and adverse events were consistent with those previously reported for Tarceva in NSCLC.
  • The FDA is expected to make a decision on Tarceva's approval by 18 January 2010.
  • Tarceva is a daily pill developed by OSI Pharmaceuticals Inc and Genentech Inc, a company of Roche.
  • The study enrolled patients who had not progressed after first-line treatment with platinum-based chemotherapy.

Statistics:

  • 12 to 1: The vote against recommending approval of Tarceva for first-line maintenance use in advanced or metastatic NSCLC.
  • 95%: The percentage of patients in the SATURN study who experiences a statistically significant improvement in PFS with Tarceva compared to placebo.
  • 24.7 months: The median progression-free survival (PFS) in patients receiving Tarceva in the SATURN study.
  • 17.9 months: The median progression-free survival (PFS) in patients receiving placebo in the SATURN study.
  • 49.8%: The overall survival (OS) rate at 12 months in patients receiving Tarceva in the SATURN study.
  • 38.9%: The overall survival (OS) rate at 12 months in patients receiving placebo in the SATURN study.

Sources:

  • OSI Pharmaceuticals Inc press release, 17 December 2009
  • Genentech Inc press release, 17 December 2009