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On September 21, 2020, Roche announced that China's State Drug Administration (NMPA) had approved the treatment of Avastin ® (Avastin; generic name: bevasta monoantitic injection) for adult patients with relapsed glioblastoma (GBM).
In present, Avetin ® has been approved in China for the treatment of metastatic colorectal cancer, as well as non-removable advanced, metastatic or relapsed non-squamous cell non-small cell lung cancer patients first-line treatment.
approval of the new adaptation will bring new treatment options to patients with glioblastoma in China.
glioblastoma is the most common and malignant primary intracranial tumor in adults.
The 2017 China Cancer Registry Annual Report shows that the incidence of brain tumors in China is 761 per 100,000, of which glioblastoma accounts for 46.1% of malignant brain tumors, the annual incidence rate is about 2.8 per 100,000, with high morbidity, high recurrence rate, high mortality rate and low cure rate, is considered to be one of the most difficult tumors in neurosurgery.
China Anti-Cancer Association Cerebral Glioma Committee Chairman, the First Chairman of the Chinese Physicians Association Professional Committee on Glioma, Deputy Director of the Beijing Institute of Neurosurgery, Deputy Director of the Beijing Tiantan Hospital Neurosurgery Center affiliated with Capital Medical University, Professor Jiang Tao said: "At present, The treatment of glioblastoma in China is mainly surgery-based, standardized radiotherapy, chemotherapy, regular review as a supplement."
But even after standard postoperative release and chemotherapy, the prognosis of patients is still poor, almost all patients will relapse after first-line treatment, five-year survival rate is very low, neurocognitive function and quality of life are decreased.
of the central nervous system, represented by malignant glioma, has caused a huge family and social burden.
" cerebral edema and intracranial pressure increase in the course of treatment of glioma, commonly used corticosteroid hormones for the corresponding treatment.
but the high dose of corticosteroid hormones may lead to high blood pressure, osteoporosis, stomach ulcers and other side effects, resulting in a further decline in the patient's immunity, to a large extent affecting the quality of life of patients.
Avivitin® (Beva Beva bead monoantigen injection) was approved for the treatment of adult relapsed glioblastoma based primarily on a multi-center, open-label, randomized controlled critical Phase III clinical trial EORTC 26101.
the results confirmed that treatment based on avetin ® (bevazhu monoantigen injection) extended the time of disease-free progression or death compared to chemotherapy alone (medium 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%.
patients with disease remission showed more stable global health scores and cognitive function than non-remissioners during life without progression.
" glioblastoma has an extremely rich range of abnormal new blood vessels.
by targeting VEGF, a key regulatory molecule in the angiogenesis process, beva beads can reduce tumor angiogenesis, thereby inhibiting tumor growth and angiogenic cerebral edema.
"Professor Mao Ying, Chairman-designate of the Neurosurgery Branch of the Chinese Medical Association and Dean of Huashan Hospital affiliated with Fudan University, said, "Beva Zhudan can also normalize the vascular function and structure of tumors with high morphological disorders and high pipe wall permeability, and transfer chemotherapy drugs more effectively to tumor tissues to enhance the sensitivity of tumor cells to chemotherapy drugs."
for more in-depth coverage mechanisms, as well as the accumulation of clinical experience, for patients with gliomas to be specifically applied.
Professor Chen Zhongping, Chairman of the Committee of Neuro-Oncology of the Chinese Anti-Cancer Association and Director of the Cancer Prevention and Control Center of Zhongshan University, said: "Compared to traditional therapies, beva bead monoantigen can prolong the progression of patients with relapsed gliomas, reduce their dependence on corticosteroids, and effectively improve the quality of life of patients."
The approval of the beva bead monoantion makes up for the gap in the field of relapsed glioblastoma treatment in China, which is of great significance for improving the level of diagnosis and treatment of relapsed glioblastoma in China, and will bring good news to the vast number of patients who lack effective treatment plan.
" beva bead monoantigen is one of the most important therapeutic drugs in the treatment of glioblastoma after estrogen.
As a recommended treatment for patients with relapsed glioblastoma,
has been included in the NCCN, ESMO, National Health And Wellness Commission "Guidelines for diagnosis and treatment of glioma", China's central nervous system glioma targeted immunity and electric field therapy expert consensus, including domestic and foreign authoritative guidelines and consensus, has also been approved for the treatment of glioblastoma in more than 80 countries and regions such as the United States, Switzerland, Japan, South Korea.
, president of Roche Pharmaceuticals China, said: "This year is the 10th anniversary of ®'s entry into China.
, the world's first anti-tumor angiogenesis treatment, Avetin ® has benefited more than 300,000 patients with colorectal and non-small cell lung cancer in China.
approval of the glioblastoma adaptation once again reflects the Chinese government's commitment to improving people's health and practicing the healthy China strategy.
future, we will continue to uphold the concept of 'patient first needs to go', bringing more Roche innovative drugs to China to better serve Chinese patients.
"