| FDA grants Roche’s pertuzumab Priority Review |
| 08.02.12 07:39 | |
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FDA grants Roche’s pertuzumab Priority Review for previously untreated HER2-positive metastatic breast cancer Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (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. "We are pleased that the FDA has granted pertuzumab a Priority Review because new medicines are needed for HER2-positive breast cancer,” said Hal Barron, M.D., Chief Medical Officer and Head, Global Product Development. "We have been researching HER2-positive breast cancer for more than 30 years, and we hope an expedited review will help us quickly bring another personalized medicine to people battling this aggressive disease." |
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