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FDA Grants Priority Review to Breast Cancer Therapy

Mammogram (Cancer.gov)

(Cancer.gov)

Genentech in South San Francisco, California, says the Food and Drug Administration has granted priority review status to its drug pertuzumab to treat human epidermal growth factor receptor 2- (HER2-) positive breast cancer. Genentech is a division of the global pharmaceutical company Roche, headquartered in Switzerland.

FDA applies the priority review status in this case to pertuzumab when used to treat metastatic HER2-positive breast cancer or cases where the cancerous tissue cannot be removed. The review also is restricted to the use of pertuzumab when combined with the biologic drug Herceptin and the chemotherapy drug docetaxel for patients who have not received previous treatment or whose disease has relapsed after adjuvant (preliminary) therapy.

In HER2-positive breast cancer, and other types of cancers, there’s an excess of the human epidermal growth factor receptor 2 protein that promotes the growth of cancer cells. In about one of five breast cancers, this condition is caused by a gene mutation. HER2-positive breast cancers can be more aggressive than other types of breast cancer, as well as less responsive to hormone treatment.

Genentech based its biologics license application for pertuzumab, which was also granted by FDA, on a phase 3 clinical study of the drug. When combined with Herceptin and docetaxel chemotherapy, patients in the trial experienced a median progression-free survival period of 18.5 months, compared to 12.4 months for Herceptin and docetaxel alone. People receiving the full combination of drugs also experienced a 38 percent reduction in the risk of the disease worsening or death.

FDA gives priority review designation to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists.  Priority reviews means the time to review a new drug application is reduced, normally from 10 to six months. Genentech says FDA’s target date to complete its review of pertuzumab is 8 June 2012.

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