Gene therapy for glioblastoma approved today

Source: Wuxi Pharmaceutical Co., Ltd Dec 7, 2017 Genentech, a member of Roche Group, announced that the U.S FDA has approved Avastin (bevacizumab) for the treatment of adult glioblastoma patients who have progressed after treatment (known as recurrent diseases) The drug was previously temporarily approved by the FDA's accelerated approval process and was fully approved today Glioma is the most common malignant primary brain tumor, accounting for nearly one quarter of all primary brain tumors and three quarters of all malignant tumors Glioblastoma (or glioblastoma multiforme) is the most common and aggressive type of glioma, accounting for more than half of all gliomas More than 12300 people are expected to be diagnosed with glioblastoma in the United States in 2017 There are still huge unmet medical needs for this group Avastin is a kind of biological antibody, which can specifically bind to vascular endothelial growth factor (VEGF) It plays an important role in the whole tumor life cycle, helping tumor development and maintaining angiogenesis Avastin can block its interaction with receptors on vascular cells by directly binding to VEGF protein, thus interfering with tumor blood supply Tumor blood supply is considered to be the key to the ability of tumor to grow and spread in vivo It has been approved for a variety of tumor types, including metastatic colorectal cancer, advanced non squamous non-small cell lung cancer, metastatic renal cancer, advanced cervical cancer, recurrent ovarian cancer, etc It is approved to be used in adult patients with glioblastoma, which also provides a new treatment option for this group of patients Avastin's full approval was based on all its evidence in glioblastoma, including data from a phase 3 clinical trial, EORTC 26101 The trial was an independent, multicenter, randomized, open label, three-phase trial conducted by the European Organization for cancer research and treatment (EORTC) to evaluate the efficacy of Avastin plus lomustine in 432 patients who had received glioblastoma treatment The primary endpoints of the study were overall survival (OS) and progression free survival (PFS) as assessed by the investigator, and overall response rate (ORR) was the key secondary endpoint The results showed that Avastin based treatment did not significantly increase OS (HR = 0.91, P = 0.4578) Since the primary end point was not reached, all secondary end points should be treated as descriptive, Avastin based treatment prolongs the time to disease progression or death compared to chemotherapy alone (median PFS: 4.2 months vs 1.5 months, HR = 0.52, 95% CI: 0.41-0.64) of the patients taking corticosteroids at baseline (50%), more patients in the Avastin group were able to completely stop corticosteroids during the treatment period than those in the control group (23% vs 12%) In the Avastin group, 22% of the patients stopped treatment due to adverse reactions, while in the control group, 10% of the patients had adverse reactions Adverse events were consistent with previous trials in Avastin approved indications that "glioblastoma is the most common and aggressive form of brain tumor and may be difficult to treat," said Sandra, Roche chief medical officer and global product development director "Delaying disease progression and reducing the demand for corticosteroids in the treatment process is considered an important goal for patients affected by this devastating disease, with limited treatment options," Dr horning said Reference: [1] FDA grants Genentech's Avastin full approval for most aggressive form of brain cancer [2] Genentech official website