European authorisation could boost sales of Roche drug following FDA decision to revoke breast cancer approval
Roche has been given a green light by the European Commission (EC) to market its Avastin cancer drug as a front-line therapy, after surgery, for women with newly-diagnosed ovarian cancer.
Avastin (bevacizumab) is approved for use alongside chemotherapy with carboplatin and paclitaxel in this setting, and is the first major treatment advance for women with ovarian cancer in 15 years, according to the company.
The approval could lend some additional momentum to Roche's big-selling Avastin franchise, which saw sales dip last year after its approval as a treatment for breast cancer was revoked by the US Food and Drug Administration (FDA).
An agency review found that the "significant" risks of the drug were not outweighed by its benefits.
Sales of the product reached $3.9bn in the first nine months of 2011, a decline of 8 per cent, which the company attributed directly to the months of uncertainty about its use in breast cancer in the US.
The ovarian cancer approval was granted on the strength of two phase III clinical trials which showed that women with newly-diagnosed ovarian cancer lived significantly longer without disease progression when Avastin was added on top of the standard treatment regimen.
"This is the fifth tumour type for which Avastin has been approved in Europe, making it one of few biologic drugs indicated for multiple cancers," said Hal Barron Roche's chief medical officer and head of global product development.
Ovarian cancer is the eighth most commonly diagnosed cancer in women and the seventh leading cause of cancer death among women worldwide. Annually, over 220,000 women will be diagnosed with ovarian cancer around the world and about 140,000 will die from the disease.
Roche has committed to another phase III trial to try to demonstrate Avastin's worth alongside paclitaxel as a front-line treatment for breast cancer.
The drug remains on the market in Europe for advanced-stage breast cancer in combination with paclitaxel, as well as for ovarian, colorectal, non-small cell lung and kidney cancers.