Recently, Roche breast cancer drug Perjeta (pertuzumab, pertuzumab) in China's listing application received CDE contractors.
Perjeta is a monoclonal antibody. It is the first monoclonal antibody to be known as a "HER dimerization inhibitor." By binding to HER2, it blocks the heterodimerization of HER2 with other HER receptors, slowing tumor growth. Perjeta passed US FDA certification in June 2012 and is approved for use with HER2-positive breast cancer in combination with trastuzumab (trastuzumab, trastuzumab) and docetaxel, which has spread to different parts of the body ( Metastatic) and have not received anti-HER2 or chemotherapy in patients with metastatic breast cancer.
In December 2017, the U.S. FDA approved triple therapy with Perjeta plus Hirschsting and Chemotherapy (Perjeta-based regimens) as a postoperative adjuvant therapy for HER2-positive patients with early-stage breast cancer (EBC) at high risk of recurrent disease. Patients need to receive Perjeta-based adjuvant therapies for one year (up to 18 cycles). The FDA also approved the accelerated approval of the (preoperative) neoadjuvant therapy previously issued to this Perjeta-based treatment program to be fully approved for use in HER2-positive, locally advanced, inflammatory or early-stage breast cancers (> 2 cm in diameter or lymph nodes positive )patient.
FDA's approval last year was based on the results of a Phase 3 clinical study of APHINITY. APHINITY is a randomized, double-blind, placebo-controlled, multicenter international arms study to evaluate the efficacy of triple adjuvant therapy with Perhexidine plus Herceptin and chemotherapy compared to Herceptin and Chemotherapy Dual Therapy And safety. The study included 4,805 HER2-positive, operable EBC patients. The primary endpoint of the study was invasive disease-free survival (iDFS). Secondary end points included heart and overall safety, overall survival (OS), disease-free survival (DFS) and health-related quality of life. The study will keep participants' follow-up for a decade.
The median time to initial APHINITY analysis was 45.4 months. The results showed that in the overall study population, triple therapy with Perjeta plus Hemostatine and chemotherapy significantly reduced the infiltration compared with dual therapy with Herceptin and Chemotherapy The risk of recurrent or fatal breast cancer was 18% (HR = 0.82, 95% CI 0.67-1.00, p = 0.047). Specific results in breast cancer patients with high-risk patients with lymph node-positive or hormone-receptor negative findings are as follows: lymph node-positive subgroup (HR = 0.77, 95% CI 0.62-0.96), lymph node-negative subgroup % CI 0.68-1.86), hormone receptor positive subgroup (HR = 0.86, 95% CI 0.66-1.13) and hormone receptor negative subgroup (HR = 0.76, 95% CI 0.56-1.04).