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FDA Approves Tarceva for Pancreatic Cancer Combination Therapy

Strategic Insights

— 2 min read

The U.S. Food and Drug Administration has approved Tarceva (erlotinib) in combination with gemcitabine chemotherapy for the treatment of advanced pancreatic cancer in patients who have not received previous chemotherapy. Tarceva is the first drug to show a significant improvement in overall survival when added to gemcitabine chemotherapy as initial treatment for pancreatic cancer.

Tarceva is a once-daily oral tablet that has already been approved for use in patients with non-small cell lung cancer (NSCLC) whose disease has progressed after one or more courses of chemotherapy. The approval of Tarceva for pancreatic cancer is a significant milestone in the treatment of this devastating disease, which has a poor prognosis and high mortality rate. According to The Pancreatic Cancer Action Network, the average life expectancy for a patient diagnosed with metastatic pancreatic cancer is three to six months.

Key Takeaways:

  • Tarceva (erlotinib) has been approved by the FDA in combination with gemcitabine chemotherapy for the treatment of advanced pancreatic cancer in patients who have not received previous chemotherapy.
  • Tarceva is the first drug to show a significant improvement in overall survival when added to gemcitabine chemotherapy as initial treatment for pancreatic cancer.
  • The approval of Tarceva for pancreatic cancer is a significant milestone in the treatment of this devastating disease, which has a poor prognosis and high mortality rate.
  • Patients with pancreatic cancer have a 23% improvement in overall survival when receiving Tarceva plus gemcitabine compared to gemcitabine plus placebo.
  • The disease control rate (complete response + partial response + stable disease) was significantly improved (59% in patients receiving Tarceva plus gemcitabine versus 49% in the gemcitabine plus placebo arm, p = 0.036).
  • The most common adverse events reported were fatigue, rash, nausea, anorexia, and diarrhea.
  • Tarceva has a well-established safety profile, with 2% of patients discontinuing the drug due to rash and 2% due to diarrhea.

Statistics:

  • The approval of Tarceva for pancreatic cancer is a significant milestone in the treatment of this devastating disease, which has a poor prognosis and high mortality rate.
  • According to The Pancreatic Cancer Action Network, the average life expectancy for a patient diagnosed with metastatic pancreatic cancer is three to six months.
  • Patients with pancreatic cancer have a 23% improvement in overall survival when receiving Tarceva plus gemcitabine compared to gemcitabine plus placebo (hazard ratio = 0.81; p = 0.028).
  • After one year, 24% of patients receiving Tarceva plus gemcitabine were alive compared to 19% of patients receiving gemcitabine plus placebo.

Sources:

  • OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) press release, "OSI Pharmaceuticals, Inc. and Genentech, Inc. Announce FDA Approval of Tarceva in Combination with Gemcitabine for the Treatment of Advanced Pancreatic Cancer"
  • Genentech, Inc. (NYSE: DNA) press release, "Genentech and OSI Pharmaceuticals Announce FDA Approval of Tarceva in Combination with Gemcitabine for the Treatment of Advanced Pancreatic Cancer"
  • The Pancreatic Cancer Action Network (PanCAN) website, "Pancreatic Cancer Facts"

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