Amgen Completes BLA Submission for Panitumumab in Metastatic Colorectal Cancer

Amgen has completed the Biologic License Application (BLA) submission with the U.S. Food and Drug Administration (FDA) for panitumumab, a potential indication for the treatment of metastatic colorectal cancer in patients who have failed prior chemotherapy. The rolling BLA submission was initiated in December 2005, and the company's goal is to make panitumumab accessible to patients with metastatic colorectal cancer who have exhausted available treatment options. The drug has shown promising results in clinical trials, including a 46% decrease in tumor progression rate in patients who received panitumumab every 2 weeks compared to those who received best supportive care alone.

Key Takeaways:

• Amgen has completed the BLA submission for panitumumab with the FDA for the treatment of metastatic colorectal cancer.
• The potential indication is for patients who have failed prior chemotherapy, including oxaliplatin and/or irinotecan containing regimens.
• Panitumumab is a fully human monoclonal antibody that targets the epidermal growth factor receptor (EGFr) and has shown a 46% decrease in tumor progression rate in clinical trials.
• The drug was generated with XenoMouse technology, which creates a fully human monoclonal antibody that contains no murine (mouse) protein.
• Panitumumab received Fast Track designation from the FDA in July 2005 for patients with metastatic colorectal cancer who have failed standard chemotherapy treatment.

Statistics:

• 463 patients were involved in the randomized phase III trial that showed a 46% decrease in tumor progression rate in patients who received panitumumab every 2 weeks.
• The results surpassed expectations based on preset measurement criteria in the protocol.
• 46% decrease in tumor progression rate was observed in patients who received panitumumab versus those who received best supportive care alone.

Sources:

• World Disease Weekly editors, 2006, World Disease Weekly via NewsRx.com.