Roche’s Avastin for Recurring Ovarian Cancer Approved in Europe
The European Commission approved Roche’s cancer drug Avastin in combination with chemotherapy to treat women with recurring ovarian cancer that is resistant to platinum-containing chemotherapy.
The new indication is for patients who have received no more than two prior chemotherapy treatments but who have never received Avastin (bevacizumab), Roche said.
The approval was based on results of a Phase III trial in which women given Avastin with chemotherapy experienced a near-doubling of median progression-free survival compared with women given chemotherapy alone (6.7 months versus 3.4 months). The study also showed that women who received Avastin had significantly greater tumor shrinkage than did women who received chemotherapy alone.
Avastin is the first biologic approved in the EU to treat this kind of cancer, said Roche Chief Medical Officer Sandra Horning. There are roughly 44,000 cases of ovarian cancer in the EU every year, and some 30,000 deaths, according to Roche. The drug is manufactured by Roche subsidiary Genentech.
In the EU, Avastin already is indicated for breast cancer, colorectal cancer, non-small cell lung cancer, kidney cancer and ovarian cancer, including first recurrence of platinum-sensitive ovarian cancer.
The FDA late last month gave the drug priority review for platinum-resistant recurring ovarian cancer.
The agency initially approved Avastin in 2004 to treat colorectal cancer, and has since approved indications for treating non-small cell lung cancer, progressive glioblastoma and kidney cancer. In November 2011, however, the FDA revoked its approval for breast cancer due to lack of evidence that it helped women live longer or better.
Roche says it is studying the drug in more than 500 clinical trials and more than 50 different types of cancer. — Lena Freund
Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.