Friday, November 16, 2012

Roche receives positive opinion from European Medicines Agency for Avastin based treatment beyond first progression in people with advanced colorectal cancer

The positive recommendation is based on based benefit demonstrated by Avastin in the ML18147 study. The study demonstrated  continued use of Avastin based therapy beyond first progression in metastatic colorectal cancer patients leads to survival benefits. This will allow people diagnosed with metastatic colorectal cancer who receive Avastin plus chemotherapy as a first line treatment to continue to receive Avastin plus chemotherapy after their cancer worsens as a second line treatment. If Avastin is finally approved, we believe this will impact market potential of Sanofi's Zaltrap, which also received positive recommendation in colorectal patients who have progressed after receiving an oxaliplatin containing regimen.

About the ML18147 studyML18147 was a randomised, open-label phase III multicentre, multinational trial evaluating the efficacy and safety profile of Avastin plus standard second-line chemotherapy in 820 patients with mCRC whose disease had progressed following Avastin plus standard first-line chemotherapy (irinotecan or oxaliplatin-based). Patients were randomised at progression to one of two treatment arms:
• Arm A: Chemotherapy* plus Avastin (equivalent of 2.5 mg/kg i.v. per week)
• Arm B: Chemotherapy* alone
*Depending on the first-line chemotherapy backbone (fluoropyrimidine / irinotecan-based or fluoropyrimidine / oxaliplatin-based) the chemotherapy backbone was switched in the second-line setting.
The primary endpoint of the study was overall survival measured from the time patients were randomised to the second-line treatment. The secondary efficacy endpoints of the study included PFS, overall response rate and safety profile

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