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FDA grants priority review for Perjeta as neoadjuvant treatment of HER-2–positive breast cancer
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The FDA granted priority review to a pertuzumab regimen for neoadjuvant treatment of women with early-stage HER-2–positive breast cancer, according to its manufacturer.
A decision is expected by Oct. 31.
Pertuzumab (Perjeta, Genentech)— a humanized monoclonal antibody that is administered intravenously — targets the HER-2 receptor, a protein found in high concentrations on the outside of cancer cells in HER-2–positive malignancies.
Pertuzumab already is approved in combination with trastuzumab (Herceptin, Genentech) and docetaxel chemotherapy for treatment of HER-2–positive metastatic breast cancer.
Last year, the FDA issued draft guidance related to neoadjuvant treatment for early-stage breast cancer with the intention of helping promising therapies reach patients sooner. No treatments have been approved.
“The impact of treatment in breast cancer is greatest in the early stage, before the cancer has spread to other parts of the body,” Hal Barron, MD, Genentech’s chief medical officer and head of global product development, said in a press release. “We look forward to working with the FDA to bring this potential option to people with HER-2–positive early-stage breast cancer as soon as possible.”
Pathologic complete response (pCR) — defined as no detectable tumor tissue at the time of surgery — is a common measure of benefit for neoadjuvant treatment in breast cancer.
The phase 2 NEOSPHERE study — which included 417 patients with newly diagnosed, locally advanced, inflammatory or early-stage breast cancer — showed a neoadjuvant regimen with pertuzumab, trastuzumab and docetaxel chemotherapy significantly improved pCR compared with trastuzumab and docetaxel alone (45.8% vs. 29%; P=.014), according to the Genentech press release.
The phase 2 TRYPHAENA trial, which included 225 patients, showed a neoadjuvant regimen of pertuzumab, trastuzumab, docetaxel and carboplatin chemotherapy was associated with a 66.2% pCR rate. Adverse events were consistent with those reported in prior studies.
The most common side effects associated with pertuzumab in combination with trastuzumab and docetaxel are diarrhea, hair loss, neutropenia, febrile neutropenia, nausea, fatigue, rash, and tingling, numbness or pain in the hands and feet.