FDA Advisory Committee recommends accelerated approval of Roche's Perjeta for neoadjuvant use in HER2-positive early stage breast cancer

Roche today announced that the United States (U.S.) Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 13 to 0, with one abstention, in favour 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. The FDA will make a decision on whether or not to approve Perjeta for this use by 31 October, 2013. If approved, the Perjeta regimen will be the first neoadjuvant breast cancer treatment approved in the U.S. and the first treatment approved based on pathological complete response (pCR) data, meaning there is no tumour tissue detectable at the time of surgery.
Source: Roche Investor Update - Category: Pharmaceuticals Source Type: news