Oncology Drug Research, Development, and Manufacturing
PharmNet, December 20 – Reporters learned from Roche that Perjeta, an innovative targeted therapy for breast cancer developed by Roche, has recently been approved by the China National Medical Products Administration (NMPA). It is indicated for the adjuvant treatment of patients with HER2-positive early-stage breast cancer at high risk of recurrence, in combination with Herceptin and chemotherapy. The dual-targeted regimen of Perjeta and Herceptin significantly reduces the risk of recurrence or death in patients with HER2-positive early-stage breast cancer at high risk of recurrence.
It is reported that this innovative treatment regimen has been recommended in multiple guidelines and expert consensus statements in China and internationally. Breast cancer is China'sFemaleThe most common malignant tumor, ranking first in the incidence of female malignant tumors, is femaleHealth"Number One Killer."
Professor Ren Guosheng, Chairman of the Breast Cancer Professional Committee of the China Anti-Cancer Association, introduced that breast cancer is classified into four distinct subtypes. Among these, HER2-positive breast cancer accounts for approximately 20%–25% of all breast cancer cases and is characterized by a higher degree of malignancy in tumor cells,DiseaseCharacterized by more rapid progression and a higher propensity for metastasis and recurrence, it was once referred to as the “most aggressive breast cancer.”
With the advent of Herceptin, an anti-HER2 targeted therapy for breast cancer, significant progress has been made in the treatment of HER2-positive breast cancer over the past two decades, with three-quarters of patients with early-stage HER2-positive breast cancer achieving clinical cure. Nevertheless, despite these advances, 25% of patients with early-stage HER2-positive breast cancer still experience disease recurrence after current anti-HER2 therapies.
As early as 1987, Genentech, a subsidiary of Roche, not only developed the 4D5 monoclonal antibody capable of inhibiting HER2 expression (later named Herceptin), but also discovered another monoclonal antibody, 2C4, which could inhibit HER2 expression (later named Perjeta). Over the subsequent decade and more, after numerous failures and relentless research, scientists finally discovered that Herceptin and Perjeta have distinct mechanisms of action. They bind to different regions of the HER2 protein, thereby fully blocking the HER2 signaling pathway. Furthermore, they can further enhance the patient’s own immune system to clearTumorcells, effectively reducing tumor burden.
Professor Shao Zhimin, Director of the Fudan University Shanghai Cancer Center and Director of the Breast Cancer Institute, stated that the dual-target combination therapy synergistically enhances efficacy and fully blocks the HER2 signaling pathway, thereby curbing tumor cell growth at its source and further reducing the risk of recurrence in HER2-positive breast cancer. Clinical trials have demonstrated that the regimen of Perjeta plus Herceptin combined with chemotherapy reduces the risk of recurrence or death by 31% in the overall patient population in China.