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ODAC supports Perjeta approval for HER-2–positive breast cancer
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An FDA panel today unanimously expressed its support for the approval of pertuzumab for treatment of patients with HER-2–positive breast cancer.
The Oncologic Drugs Advisory Committee voted 13-0 in favor of Genentech’s supplemental biologics license application for pertuzumab (Perjeta)
Pertuzumab, a humanized monoclonal antibody that is administered intravenously, is proposed for use in combination with trastuzumab (Herceptin, Genentech) and docetaxel for neoadjuvant treatment of patients with early-stage, locally advanced or inflammatory disease.
In July, the FDA granted priority review status to the regimen for its use as neoadjuvant treatment. The regimen already is approved for treatment of HER-2–positive metastatic breast cancer.
The FDA often follows the advisory committee’s recommendations but is not obligated to do so. A decision on approval of pertuzumab for use in the neoadjuvant regimen is expected by Oct. 31.
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).
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.
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.