FDA Grants Roche's Pertuzumab Priority Review
Roche announced that the FDA has accepted the company's Biologics License Application for pertuzumab and granted Priority Review.
Roche announced that the U.S. FDA has accepted the company's Biologics License Application for pertuzumab and granted Priority Review.
The proposed indication is pertuzumab in combination with Herceptin (trastuzumab) and docetaxel chemotherapy for people with HER2-positive metastatic or locally recurrent, unresectable breast cancer, who have not received previous treatment or whose disease has relapsed after adjuvant therapy. The FDA confirmed the action date is June 8, 2012.
The pertuzumab application is based on results from the pivotal Phase III CLEOPATRA study. The study demonstrated a 6.1 month improvement in median progression-free survival (PFS) for people who received a pertuzumab-based regimen (pertuzumab combined with H
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