China Approves Avastin’s New Indication

As the world’s first anti-tumor angiogenesis treatment drug, Avastin was approved in China to treat colorectal cancer and non-small cell lung cancer ( NSCLC ) indications. On September 21, Roche announced that Avastin had been approved by the National Medical Products Administration (NMPA) of China to treat adult patients with recurrent glioblastoma (GBM).

Avastin is a humanized monoclonal antibody lgG1 developed by Roche. Avastin can bind to tumor Vascular Endothelial Growth Factor (VEGF) to not stimulate the growth of blood vessels. The blood, oxygen, and other nutrients required for tumor growth are blocked, preventing their growth or spreading to other parts of the body, and ultimately achieving anti-cancer effects.

Glioblastoma (GBM) is the most common and deadly primary brain tumor in adults. In the West, the annual incidence or number of new diagnoses is 2 to 3 per 100,000 people. GBM accounts for 12% to 15% of all intracranial tumors and 50% to 60% of astrocytoma. GBM can invade and infiltrate the normal surrounding brain tissue extensively, making complete resection impossible. Even with comprehensive treatments such as surgery, radiotherapy and chemotherapy, GBM patients are still very prone to relapse and die of tumors quickly. GBM is considered being one of the most challenging tumors in neurosurgery.

This new indication’s approval is mainly based on a multi-center, open-label, randomized controlled, pivotal phase III clinical trial EORTC 26101. This study confirmed that compared with chemotherapy alone, Avastin-based treatment prolonged the time to progression-free survival or the time to death (median PFS: 4.2 months vs. 1.5 months, HR=0.52, 95%CI: 0.41-0.64), the risk of disease progression can be reduced by 51%. During the progression-free survival period, patients in remission showed more stable global health scores and cognitive functions than non-remission patients. This means that Avastin will bring new treatment options for Chinese GBM patients. The approval of Avastin this time fills up the gap in GBM treatment in China. It is of great significance to improving the level of GBM diagnosis and treatment in China and will bring good news to patients who lack effective treatment options.

Partner Article, By James Hou, Ph.D.

Author

GeneOnline