Roche Announces NMPA Approval of Avastin (Bevacizumab Injection) for Adult Patients with Recurrent Glioblastoma in China

On September 21, 2020, Roche announced that the China National Medical Products Administration (NMPA) had approved Avastin® (English brand name: Avastin; generic name: bevacizumab injection) for the treatment of adult patients with recurrent glioblastoma (GBM). Currently, Avastin® has been successively approved in China for use in combination with chemotherapy for the treatment of metastatic colorectal cancer, and as first-line therapy for patients with unresectable advanced, metastatic, or recurrent non-squamous non-small cell lung cancer. The approval of this new indication will provide new treatment options for patients with glioblastoma in China.

Glioblastoma is the most common and most malignant primary intracranial tumor in adults. According to the 2017 Annual Report of China’s Cancer Registry, the incidence of brain tumors in China was 7.61 per 100,000 population, with glioblastoma accounting for 46.1% of malignant brain tumors. The annual incidence of glioblastoma was approximately 2.8 per 100,000 population. Characterized by high incidence, high recurrence rate, high mortality, and low cure rate, glioblastoma is considered one of the most challenging tumors to treat in the field of neurosurgery.

During the treatment of gliomas, symptoms such as cerebral edema and increased intracranial pressure are common, and corticosteroids are frequently used for symptomatic management. However, high-dose corticosteroid therapy may lead to adverse effects such as hypertension, osteoporosis, and gastric ulcers, further compromising patients’ immune function and significantly impairing their quality of life.

Avastin® (bevacizumab injection) was approved for the treatment of adult patients with recurrent glioblastoma primarily based on EORTC 26101, a pivotal, multicenter, open-label, randomized controlled Phase III clinical trial. The study results confirmed that, compared with chemotherapy alone, Avastin® (bevacizumab injection)-based therapy prolonged the time to disease progression or death (median PFS: 4.2 months vs. 1.5 months; HR=0.52; 95% CI: 0.41–0.64), reducing the risk of disease progression by 51%. During the progression-free survival period, patients who achieved disease response demonstrated more stable global health status scores and cognitive function compared to non-responders.

“Glioblastoma is characterized by an extremely rich network of abnormal neovasculature. By targeting VEGF, a key regulatory molecule in the angiogenic process, bevacizumab can reduce tumor angiogenesis, thereby inhibiting tumor growth and vasogenic cerebral edema,” stated Professor Mao Ying, President of Huashan Hospital Affiliated to Fudan University and President-Elect of the Neurosurgery Branch of the Chinese Medical Association. “Bevacizumab can also normalize both the function and structure of tumor vessels, which are typically disorganized and exhibit high wall permeability, thus facilitating more effective delivery of chemotherapeutic agents into tumor tissue and enhancing the sensitivity of tumor cells to chemotherapy. Further research into the underlying mechanisms and accumulation of clinical experience are needed to better define the specific patient populations with glioma who would benefit from this treatment.”

Professor Chen Zhongping, Director of the Neuro-Oncology Committee of the China Anti-Cancer Association and from the Sun Yat-sen University Cancer Center, stated: “Compared with traditional therapies, bevacizumab can prolong progression-free survival in patients with recurrent glioma, reduce their dependence on corticosteroids, and effectively improve their quality of life. The approval of bevacizumab fills a gap in the treatment of recurrent glioblastoma in China, holds significant importance for enhancing the diagnosis and treatment standards for this condition in the country, and will bring hope to a vast number of patients who lack effective treatment options.”

Bevacizumab is one of the most important therapeutic agents in the treatment of glioblastoma, following temozolomide. As a recommended therapy for patients with recurrent glioblastoma, it is currently included in authoritative domestic and international guidelines and consensus statements, such as those from the NCCN, ESMO, the National Health Commission’s “Standards for Diagnosis and Treatment of Gliomas,” and the Chinese Expert Consensus on Targeted Immunotherapy and Tumor Treating Fields for Central Nervous System Gliomas. It has also been approved for the treatment of glioblastoma in more than 80 countries and regions, including the United States, Switzerland, Japan, and South Korea.

Zhou Hong, President of Roche China, stated, “This year marks the 10th anniversary of Avastin®’s entry into China. As the world’s first anti-angiogenic therapy for cancer, Avastin® has benefited more than 300,000 Chinese patients with colorectal cancer and non-small cell lung cancer to date. The recent approval of Avastin® for the indication of glioblastoma further demonstrates the Chinese government’s commitment to improving public health and implementing the Healthy China strategy. Moving forward, we will continue to uphold our principle of ‘acting in the best interests of patients first’ by introducing more innovative Roche medicines to China to better serve Chinese patients.”

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