Pfizer's SUTENT Receives FDA Approval for Treatment of Pancreatic Neuroendocrine Tumors

Strategic Insights -

Pancreatic neuroendocrine tumors (NET) are rare and difficult-to-treat cancerous growths of the pancreas, affecting only two to four people per million annually. The U.S. Food and Drug Administration (FDA) has approved Pfizer's SUTENT (sunitinib malate) as the first anti-vascular endothelial growth factor (anti-VEGF) therapy for the treatment of progressive, well-differentiated pancreatic NET in patients with unresectable locally advanced or metastatic disease. This approval is a significant milestone for patients with limited treatment options, offering a new hope for improved quality of life.

Key Takeaways:

  • The FDA approval is based on data from the SUN 1111 pivotal Phase 3 trial, demonstrating SUTENT provided a clinically significant improvement in progression-free survival (PFS) compared to placebo (10.2 versus 5.4 months, p=0.000146) in patients with pancreatic NET.
  • The approval marks the third disease indication for SUTENT, which was previously approved by the FDA for treatment of patients with advanced kidney cancer and imatinib-resistant or intolerant gastrointestinal stromal tumor (GIST).
  • SUTENT has been approved for advanced pancreatic NET in Europe and nine additional countries, and is also approved for gastrointestinal stromal tumors (GIST) and advanced renal cell carcinoma (RCC) in over 100 countries.
  • The approval is welcome news for physicians who have struggled to find a treatment option that shows a substantial clinical benefit in treating advanced pancreatic NET, with Dr. Eric Raymond, principal investigator of the SUN 1111 Phase 3 trial, stating that "SUTENT represents a treatment that attacks a key component of tumor growth."
  • Pancreatic NET is a rare cancer with poor prognosis, accounting for up to 28% of all neuroendocrine tumors, with nearly 90% of patients initially diagnosed with locally advanced or metastatic disease.
  • SUTENT's safety profile includes hepatotoxicity, which has been observed in clinical trials and post-marketing experience, requiring careful monitoring of liver function tests and potential interruption of treatment.

Statistics:

  • Progression-free survival (PFS) in patients treated with SUTENT was 10.2 months, compared to 5.4 months in the placebo arm (p=0.000146) in the SUN 1111 pivotal Phase 3 trial.
  • Objective response rate (ORR) was 9.3% (95% CI: 3.2, 15.4, p=0.0066) in patients treated with SUTENT, compared to no objective responses in the placebo arm.
  • Nine deaths were observed in patients enrolled in the SUTENT arm, compared to 21 deaths in patients enrolled in the placebo arm.
  • SUTENT has been studied in over 10,000 patients in clinical trials and has been used to treat over 100,000 patients worldwide.

Sources:

  • Pfizer Inc.
  • U.S. Food and Drug Administration (FDA)
  • SUN 1111 pivotal Phase 3 trial
  • New England Journal of Medicine
  • Gene Therapy Weekly editors
  • NewsRx.com