FDA Panel Supports Genentech's Perjeta For Neoadjuvent Use In Breast Cancer

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

The company said the FDA will make a decision on whether or not to approve Perjeta for this use by October 31, 2013. If approved, the Perjeta regimen will be the first neoadjuvant breast cancer treatment approved in the United States and the first treatment approved based on pathological complete response or pCR data, meaning there is no tumor tissue detectable at the time of surgery.

Perjeta is already approved in a number of countries including the United States for people with HER2-positive metastatic breast cancer, an advanced form of the disease in which the cancer has spread to other parts of the body, the company noted.

The Perjeta application for neoadjuvant use follows a proposed new FDA pathway designed to more quickly bring promising medicines to people with earlier stages of breast cancer, where treatment may have a greater impact.

Genentech said that Neoadjuvant treatment may allow a doctor to quickly assess whether a medicine is working and may also reduce a tumor's size so it is easier to surgically remove.

The ongoing Phase III APHINITY study will further evaluate Perjeta in the adjuvant setting and compares Perjeta, Herceptin® and chemotherapy with Herceptin and chemotherapy in people with HER2-positive early stage breast cancer.