FDA grants Priority Review to Genentech’s Perjeta

Roche subsidiary, Genentech, has announced that the US FDA has accepted its 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.

There are currently no FDA-approved neoadjuvant treatments for cancer. This type of therapy is a treatment option given after diagnosis but before surgery for early stage breast cancer, as it aims to reduce the size of a tumour so it may be easier to surgically remove.

Genentech's application is based primarily on results from two phase two clinical trials of Perjeta in HER2-positive early stage breast cancer, as well as on longer-term safety data from a phase three clinical trial of Perjeta in HER2-positive metastatic breast cancer.

"The impact of treatment in breast cancer is greatest in the early stage, before the cancer has spread to other parts of the body. 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."

Hal Barron, M.D., chief medical officer and head, Global Product Development.

The FDA has granted a Priority Review of Genentech's application and will make a decision on approval by October 31st 2013. The FDA grants Priority Review designation to medicines it believes have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.

Perjeta is already approved in the United States and Europe for people with HER2-positive metastatic breast cancer, an advanced form of the disease.