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FDA Advisory Committee Recommends Accelerated Approval of Perjeta for Neoadjuvant Use in HER2-positive Early Stage Breast Cancer

September 13, 2013

Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 13 to 0, with one abstention, in favor of recommending accelerated approval of a Perjeta® (pertuzumab) regimen for neoadjuvant treatment (use before surgery) in people with high-risk, HER2-positive early stage breast cancer.

Sep 12, 2013 - Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 13 to 0, with one abstention, in favor of recommending accelerated approval of a Perjeta® (pertuzumab) regimen for neoadjuvant treatment (use before surgery) in people with high-risk, HER2-positive early stage breast cancer.

Read Genentech's Press Release, here.

Read OncLive.com coverege, here.

Listen to AJMC's panel discussion, Treatment and Cost Implications of Pertuzumab and Trastuzumab, here.