AVASTIN receives Health Canada approval for patients with GBM

AVASTIN now approved to treat colorectal, breast, lung and brain cancer

Roche Canada announced today that Health Canada has approved AVASTIN(R) (bevacizumab), as a single agent, for the treatment of patients with glioblastoma multiforme (GBM), the most aggressive primary malignant brain tumour, after relapse or disease progression, following prior therapy. AVASTIN has been issued a notice of compliance with conditions (NOC/c), pending the results of confirmatory studies to verify its clinical benefit. Products authorized under Health Canada's NOC/c policy are intended for the treatment, prevention or diagnosis of a serious, life-threatening or severely debilitating illness. They have demonstrated promising benefit, are of high quality and possess an acceptable safety profile based on a benefit/risk assessment. Health Canada has provided access to this product on the condition that the sponsor submit the results of additional clinical trials to verify the benefit within an agreed upon time frame.

Patients with GBM have a very poor prognosis and a mortality rate that has changed little in the past decade. The vast majority of GBM patients will also see their cancer return. Treatment options for patients with relapsed or progressive GBM are currently limited, but may include a combination of surgery, radiation and chemotherapy. Median survival following progression of this cancer is three to nine months.

"Patients who have recurrent progressive GBM have very limited therapeutic options. The approval of AVASTIN for these patients provides a desperately needed therapeutic alternative. Studies evaluating AVASTIN for patients with recurrent and progressive GBM have shown unprecedented clinical and radiographic responses," said Dr. Warren Mason, Medical Director, The Gerry & Nancy Pencer Brain Tumor Centre at The Princess Margaret Hospital in Toronto. "AVASTIN is generally well-tolerated by these patients, and enables many to reduce their daily steroid requirements. The Health Canada approval of AVASTIN for recurrent GBM will change how patients with GBM are treated in this country."

AVASTIN is the first new systemic treatment in this area for over a decade and offers patients the chance for progression-free survival (defined as the percentage of patients who remained alive and progression-free at 24 weeks). The effectiveness of AVASTIN in glioblastoma multiforme is based on an improvement in objective response rate, which is defined as the percentage of patients with a complete or partial response. There are no data demonstrating an improvement in disease-related symptoms or increased survival with AVASTIN.

Results from the pivotal BRAIN (AVF3708g) study showed the potential for additional positive impact on patients' daily lives. Of those patients who responded to AVASTIN-based therapy, a majority had a stabilization or improvement in neurocognitive function at the time of the response and a reduction in their dose of steroids from baseline. Adverse events in the BRAIN study were consistent with those previously seen with AVASTIN and no new safety signals were reported. The most frequently reported adverse events in patients treated with AVASTIN alone were fatigue (45%), headache (37%), high blood pressure (30%), diarrhea (21%) and nose bleeds (19%). In addition, there were low rates of discontinuation of AVASTIN due to adverse events.

AVASTIN is already approved by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed or progressive GBM.

Roche continues to further explore the role of AVASTIN in GBM through various studies including the AVAGLIO pivotal trial, a large phase III randomized study in over 900 patients with newly diagnosed GBM. A comprehensive clinical programme with over 450 clinical trials is investigating the use of AVASTIN in various tumour types (including colorectal, breast, non-small cell lung, brain, gastric, ovarian, prostate and others) and different settings (advanced or early stage disease). Over half a million patients around the world have been treated with AVASTIN so far.

Source: ROCHE