The US Food and Drug Administration (FDA) approved pertuzumab (Perjeta) in combination with trastuzumab (Herceptin) and chemotherapy (the Perjeta-based regimen) for adjuvant treatment of HER2-positive early breast cancer at high risk of recurrence.
In addition, the previously granted accelerated approval of this regimen for neoadjuvant treatment of HER2-positive, locally advanced, inflammatory, or early stage breast cancer (more than 2 cm in diameter or node-positive) has been converted to full approval.
Recommended treatment of adjuvant therapy with the Perjeta-based regimen is for 1 year (up to 18 cycles). Recommended treatment in the neoadjuvant setting is to continue pertuzumab and trastuzumab after surgery to complete 1 year of treatment.
Pertuzumab is a monoclonal antibody designed to prevent the HER2 receptor from pairing with other HER receptors (EGFR/HER1, HER3, and HER4) on the surface of cells. This action may also signal immune system activity to destroy the cancer cells. Although both pertuzumab and trastuzumab bind to the HER2 receptor, they do so to different places. Their complementary mechanisms of action is believed to provide a more comprehensive blockade of HER signaling pathways, thus preventing tumor cells growth and survival.
Approval for adjuvant treatment is based on the results of the phase 3 APHINITY study (ClinicalTrials.gov Identifier: NCT01N358877). Invasive breast cancer recurrence or death was reduced by 18% in patients receiving the pertuzumab, trastuzumab, and chemotherapy regimen compared with trastuzumab and chemotherapy alone (hazard ratio = 0.82; 95% CI, 0.67-1.00; P =.047).
The most commonly reported grade 3-4 adverse effects were low WBCs with or without a fever, diarrhea, decrease in certain types of WBCs, decrease in RBCs, fatigue, nausea, and mouth blisters or sores. The most common side effects of pertuzumab are diarrhea, nausea, hair loss, fatigue, nerve damage, and vomiting.
Pertuzumab is also approved for use in combination with trastuzumab and docetaxel in patients with metastatic HER2-positive breast cancer who have not received anti-HER2 therapy or chemotherapy for metastatic breast cancer.
FDA approves Genentech’s Perjeta (pertuzumab) for adjuvant treatment of specific type of early breast cancer [news release]. South San Francisco, CA: Genentech, a member of the Roche Group; December 20, 2017.