FDA Approves Tarceva for Advanced Pancreatic Cancer Treatment
The U.S. Food & 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, a once-daily oral tablet, has shown a significant improvement in overall survival when added to gemcitabine chemotherapy as initial treatment for pancreatic cancer. This marks a notable step forward in treating a disease with a poor prognosis, offering a new treatment option with a proven survival benefit for patients.
Key Takeaways:
- Tarceva (erlotinib) has been approved by the FDA in combination with gemcitabine chemotherapy for the treatment of advanced pancreatic cancer.
- The combination has shown a significant improvement in overall survival in a phase III clinical study.
- Tarceva is the first FDA-approved therapy in 9 years to demonstrate an improvement in overall survival for pancreatic cancer patients.
- The FDA based its approval decision on a randomized, double-blind, placebo-controlled, phase III clinical study.
- OSI Pharmaceuticals and Genentech have announced that Roche, their international partner for Tarceva, has submitted a marketing authorization application to the European Health Authorities for Tarceva for the treatment of pancreatic cancer.
- Dr. Malcolm Moore, study chair and medical oncologist, stated that erlotinib represents a notable step forward for patients and healthcare providers in treating a disease with a poor prognosis.
- Gabe Leung, president of OSI Pharmaceuticals' oncology, said that they are pleased that pancreatic cancer patients now have a new treatment option with a proven survival benefit.
Statistics:
- 9 years: the time since the last FDA-approved therapy for pancreatic cancer demonstrated an improvement in overall survival.
- 1: the first drug in a phase III trial to have shown a significant improvement in overall survival when added to gemcitabine chemotherapy as initial treatment for pancreatic cancer.
- Percentage: not specified in the text, but Tarceva has shown a significant improvement in overall survival.
- Number of patients: not specified in the text, but the study included patients with unresectable locally advanced or metastatic pancreatic cancer.
Sources:
- OSI Pharmaceuticals, Inc. (OSIP) and Genentech, Inc. (DNA) press release
- U.S. Food & Drug Administration (FDA) approval announcement
- Health & Medicine Week via NewsRx.com