Roche is looking for expanded approval in Europe of its blockbuster Avastin for the treatment of the most aggressive type of brain cancer.
The Swiss major has filed Avastin (bevacizumab) for the treatment of patients with previously-treated glioblastoma, The file is based on a Phase II study which showed that 43% of previously-treated patients who were given the drug alone lived six months without their brain cancer advancing. The data also showed that when Avastin was combined with irinotecan, this figure increased to 50%.
Some 28% of patients responded to Avastin as a single agent, meaning tumours decreased in size by at least 50%, rising to 38% when combined with irinotecan, while those receiving Avastin alone had a median overall survival of 9.3 months compared to 8.8 months for those receiving the Roche drug in combination with irinotecan.
Most adverse events appeared to be similar to those previously reported in other Avastin studies, Roche noted, adding that the data was used by Genentech, when the majority-owned and takeover target filed the drug in this indication in the USA last month. The two firms plan to initiate a global phase III study in people with newly- diagnosed glioblastoma in the first half of 2009 that will evaluate Avastin with standard of care chemotherapy and radiation.
Roche noted that following initial treatment with chemotherapy and radiation, more than 90% of patients with glioblastoma will see their cancer return and there are few effective treatments when the initial therapy stops working. Median survival following progression of the disease is typically three to six months.
Avastin is currently approved as a treatment for patients with colon, lung and breast cancers.
