FDA Advisory Committee Recommends Approval of Tarceva for Pancreatic Cancer Treatment

Strategic Insights -

The U.S. Food and Drug Administration's Oncologic Drug Advisory Committee (ODAC) has voted 10-3 in favor of recommending approval of Tarceva (erlotinib) in combination with gemcitabine for the treatment of advanced pancreatic cancer in patients who have not received previous chemotherapy. This decision marks a significant breakthrough in the treatment of pancreatic cancer, a disease with a poor prognosis. Tarceva, an oral tablet developed by OSI Pharmaceuticals, has shown a statistically significant improvement in survival of patients suffering from advanced pancreatic cancer in a randomized clinical trial.

Key Takeaways:

  • The ODAC voted 10-3 in favor of recommending approval of Tarceva for the treatment of advanced pancreatic cancer.
  • Tarceva is the first drug in a phase III trial to have shown a significant improvement in overall survival when added to gemcitabine chemotherapy in first-line pancreatic cancer.
  • The FDA will now review the ODAC recommendation and a decision on Tarceva approval is anticipated by November 2, 2005.
  • Pancreatic cancer has the highest 1-year mortality rate of any cancer, with an average life expectancy of 3-6 months for patients diagnosed with metastatic pancreatic cancer.
  • Tarceva is currently approved for use in non-small cell lung cancer for patients whose disease has progressed after one or more courses of chemotherapy.
  • This recommendation marks a new advance in the struggle against pancreatic cancer, which has a tremendous need for new treatment options.
  • OSI Pharmaceuticals' CEO, Colin Goddard, PhD, expressed pleasure with the recommendation and looks forward to the FDA's decision on the pancreatic cancer application.

Statistics:

  • 10-3: The vote in favor of recommending approval of Tarceva for the treatment of advanced pancreatic cancer.
  • 3-6 months: The average life expectancy for a patient diagnosed with metastatic pancreatic cancer.
  • 100%: The 1-year mortality rate of pancreatic cancer, which is the highest among all cancers.
  • 9 years: The time period since a new therapy has shown a statistically significant improvement in survival of patients suffering from advanced pancreatic cancer.

Sources:

  • World Disease Weekly editors via NewsRx.com (2005)