Roche and Genentech’s oncology blockbuster Avastin has received a recommendation from a US advisory panel for approval as a treatment of the most aggressive type of brain cancer.
Genentech has confirmed that the US Food and Drug Administration Oncologic Drugs Advisory Committee has voted unanimously (10-0) that the response seen with Avastin (bevacizumab) in people with previously-treated glioblastoma “is of sufficient magnitude to be reasonably likely to predict clinical benefit”. The recommendation is based on a Phase II, non-comparative study of 167 patients with previously-treated brain cancer who took Avastin alone, or Avastin plus chemotherapy.
Data from the group of 85 patients on bevacizumab only showed that tumours were reduced to at least half their original size in 28% of the cases. Of these cases, half had a response of at least 5.6 months and 43% lived for six months without disease progression. Half of the patients survived for at least 9.3 months after starting treatment, and 38% lived longer than a year.
The FDA is expected to make a decision whether to grant accelerated approval of Avastin “for use in this most aggressive form of brain cancer” by May 5, Genentech said. Its senior vice president of clinical haematology and oncology, David Schenkein, added that “we look forward to working with the FDA to potentially provide people with this devastating disease the first new treatment in more than a decade”.
Dr Schenkein also confirmed that a global Phase III trial evaluating Avastin in people with newly diagnosed glioblastoma will be initiated later this year. Full results from that trial are expected in 2014.
Avastin is currently approved as a treatment for patients with colon, lung and breast cancers and a fresh approval is likely to push up US sales of the drug, which reached $2.7 billion last year. Some 10,000 patients are diagnosed with glioblastoma each year, according to figures from the American Cancer Society.
The estimated cost for a course of Avastin for glioblastoma is likely to be in the region of $40,000.
