U.S. health regulators have granted a priority review for Roche Holding AG's (ROG.VX) experimental breast cancer drug pertuzumab, opening the way for a launch as early as 2012 for a product the Swiss company hopes can contain damage from lost sales when top seller Herceptin loses patent protection in a few years' time.
The U.S. Food and Drug Administration gave priority review status to the medicine, a humanized monoclonal antibody, after clinical trials using breast cancer patients showed it added six months to the time before their disease worsened. Breast cancer is the most common cancer among women worldwide.
Patients in the Phase III CLEOPATRA study who received pertuzumab in combination with Herceptin - another Roche breast cancer drug - and a chemotherapy agent called docetaxel lived for an average of 18.5 months without their tumors growing. That compared with 12.4 months for those who got only Herceptin and docetaxel.
People who received the combination also experienced a 38% reduction in the risk of their disease worsening or death.
This new Anti-Her therapy coupled with mTOR inhibitors are both very promising news for breast cancer patients.
Tony Talebi, MD
The goal of combining pertuzumab with Herceptin and chemotherapy is to determine if the combination may provide a more comprehensive blockade of HER signalling pathways. Will it be applicable for PCT patent applications?
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