FDA Advisory Committee Votes Against Approval of Tarceva for Non-Small Cell Lung Cancer

Strategic Insights -

In a meeting held recently, the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 12 to one against recommending the approval of Tarceva for first-line maintenance use in patients with advanced or metastatic non-small cell lung cancer (NSCLC) whose cancer has not progressed following first-line treatment with platinum-based chemotherapy. The committee's 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.

Key Takeaways:

  • The FDA is expected to make a decision on the approval of Tarceva by January 18, 2010, despite the advisory committee's recommendation against approval.
  • The SATURN study enrolled 889 patients with advanced NSCLC and showed a 41 percent improvement in PFS with Tarceva compared to placebo in the NSCLC maintenance setting.
  • The co-primary endpoints of the study were PFS in all patients and PFS in patients whose tumors over-expressed EGFR as assessed by immunohistochemistry (IHC).
  • The study also showed a 45 percent improvement in PFS in patients whose tumors over-expressed EGFR and a 23 percent improvement in OS with Tarceva compared to placebo.
  • The most commonly reported adverse events in patients who received Tarceva were rash (49 percent) and diarrhea (20 percent).
  • Grade 3 rash and diarrhea were experienced by six percent and two percent of patients, respectively.
  • OSI Pharmaceuticals and Genentech will work closely to address the committee's comments and explore further with regulatory agencies how best to pursue the outcome of maintaining initial benefit from cytotoxic chemotherapy.

Statistics:

  • 12 to 1 vote against recommending the approval of Tarceva for first-line maintenance use in patients with advanced or metastatic NSCLC.
  • 41 percent improvement in PFS with Tarceva compared to placebo in the NSCLC maintenance setting (hazard ratio=0.71, p
  • 45 percent improvement in PFS in patients whose tumors over-expressed EGFR with Tarceva compared to placebo (hazard ratio=0.69, p
  • 23 percent improvement in OS with Tarceva compared to placebo (hazard ratio=0.81, p=0.0088; median OS 12.0 months vs. 11.0 months).
  • Rash was experienced by 49 percent of patients who received Tarceva.
  • Diarrhea was experienced by 20 percent of patients who received Tarceva.
  • Grade 3 rash and diarrhea were experienced by six percent and two percent of patients, respectively.

Sources:

  • OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) press release, "OSI Pharmaceuticals and Genentech Announce Results of the SATURN Study," November 16, 2009.
  • Genentech, Inc. press release, "Genentech and OSI Pharmaceuticals Announce Results of the SATURN Study," November 16, 2009.
  • Business Wire, "Photos/Multimedia Gallery Available: OSI Pharmaceuticals and Genentech Announce Results of the SATURN Study," November 16, 2009.