Roche has received good news from regulators in the USA after they gave the green light to Genentech’s blockbuster Avastin as a treatment for brain cancer.
The US Food and Drug Administration has granted accelerated approval of Avastin (bevacizumab) for people with glioblastoma with progressive disease following prior therapy. The approval is based on an improvement in objective response rate revealed in a Phase II study and Genentech noted that no late-stage data are available yet from trials “demonstrating an improvement in disease-related symptoms or increased survival with Avastin in glioblastoma”.
The thumbs-up was expected, coming a month after the FDA’s Oncologic Drugs Advisory Committee voted unanimously (10-0) that the response seen with Avastin in people with previously-treated glioblastoma “is of sufficient magnitude to be reasonably likely to predict clinical benefit”. The approval is based on a Phase II, non-comparative study of 167 patients and 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.
The company cited Timothy Cloughesy, director of neuro-oncology at the Jonsson Comprehensive Cancer Center at the University of California, as saying that “people with this type of brain cancer have had no new treatments in more than a decade”. Given that, “after so many years with little progress in this field, Avastin was associated with a durable tumour response and doctors now have a new medicine to offer patients”.
Genentech chief medical officer Hal Barron said that a global Phase III trial in patients with newly-diagnosed glioblastoma will soon begin enrollment “to further evaluate Avastin in this setting”. The disease affects 10,000 people per year in the USA and glioblastoma tumours nearly always return following initial treatment, the firm noted.
This is a boost for Avastin, which already used for advanced breast, lung and colon tumors, as it comes a couple of weeks after Genentech and Roche unveiled disappointing data from a Phase III study looking at the treatment’s effectiveness in early-stage colon cancer. The drug had first-quarter sales of 1.49 billion francs, up 30%.
