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Roche Perjeta (pertuzumab) PDUFA

10/31/2013 - 00:00

Monday, Jul 1, 2013
FDA Grants Genentech's Perjeta Regimen Priority Review for Use Before Surgery in HER2-Positive Early Stage Breast Cancer

Application follows proposed new FDA pathway designed to help bring promising medicines to people with earlier stages of breast cancer faster
Perjeta is one of the first medicines the FDA will evaluate as an option given before surgery (neoadjuvant treatment)
Perjeta, in combination with Herceptin and chemotherapy, was approved by the FDA in 2012 for HER2-positive metastatic breast cancer

South San Francisco, Calif. -- July 1, 2013 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) for the use of a Perjeta® (pertuzumab) regimen before surgery (neoadjuvant treatment) in people with HER2-positive early stage breast cancer. The FDA has granted a Priority Review of the application and will make a decision on approval by October 31, 2013.
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