Genentech's Perjeta regimen gets FDA Priority Review for HER2-positive early stage breast cancer

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.

“We look forward to working with the FDA to bring this potential option to people with HER2-positive early stage breast cancer as soon as possible.”

"The impact of treatment in breast cancer is greatest in the early stage, before the cancer has spread to other parts of the body," said Hal Barron, M.D., chief medical officer and head, Global Product Development. "We look forward to working with the FDA to bring this potential option to people with HER2-positive early stage breast cancer as soon as possible."

Neoadjuvant therapy is a treatment option given after diagnosis but before surgery for early stage breast cancer (cancer that has not spread beyond the breast or lymph nodes). Neoadjuvant treatment aims to reduce a tumor's size so it may be easier to surgically remove, or to allow for breast-conserving surgery. There are currently no FDA-approved neoadjuvant treatments for cancer. A common measure of neoadjuvant treatment effect in breast cancer is pathological complete response (pCR), which means there is no tumor tissue detectable at the time of surgery. Perjeta is already approved in the United States and Europe for people with HER2-positive metastatic breast cancer, an advanced form of the disease.

Perjeta is a personalized medicine that targets the HER2 receptor, a protein found in high quantities on the outside of cancer cells in HER2-positive cancers. The combination of Perjeta, Herceptin^® and docetaxel chemotherapy is thought to provide a more comprehensive blockade of HER signaling pathways.

A Priority Review designation is granted to medicines that the FDA believes have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.

The application is based primarily on results from NEOSPHERE and TRYPHAENA, two Phase II studies of Perjeta in HER2-positive early stage breast cancer, as well as on longer-term safety data from the Phase III CLEOPATRA study of Perjeta in HER2-positive metastatic breast cancer.