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Genentech's BLA for pertuzumab receives priority review status in previously untreated HER2-positive metastatic breast cancer indication
Tuesday, February 07 2012 | Comments
What's This?
The Food and Drug Administration granted Genentech Inc.'s Biologics License Application (BLA) for pertuzumab priority review status.Genentech is seeking approval for the use of pertuzumab in combination with the firm's Herceptin (trastuzumab) and docetaxel in patients with human epidermal growth factor receptor 2-positive metastatic or locally recurrent, unresectable breast cancer who have not received previous treatment or whose disease has relapsed after adjuvant therapy.
The BLA was based on data from the pivotal Phase III CLEOPATRA study. Median progression-free survival was 18.5 months among the patients who received the pertuzumab-based regimen and 12.4 months among those who received Herceptin and chemotherapy alone. The individuals who received the pertuzumab combination also experienced a 38 percent reduction in the risk of disease progression or death during follow-up. Both of these between-group differences were significant.
The Prescription Drug User Fee Act action date for the pertuzumab BLA is June 8.
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