Roche eyes ovarian cancer expansion for Avastin
pharmafile | February 8, 2011 | News story | Sales and Marketing | Cancer, Roche, avastin, bevacizumab, ovarian cancer
Roche has submitted an EU marketing authorisation for Avastin for the treatment of ovarian cancer and plans to file the drug with the FDA later this year.
Avastin (bevacizumab) is currently licensed for colorectal, breast, kidney, brain and non-small cell lung cancers, making Roche CHF 6.46 billion in sales last year.
The franchise has suffered recently, with the FDA deciding the drug should lose its breast cancer indication, potentially cutting the Swiss pharma firm’s annual revenue by $1 billion.
If approved, a new indication to treat ovarian cancer could help the flagging blockbuster and shore up a downbeat forecast for the drug.
The filings are based on the OCEANS phase III study that evaluated Avastin in combination with chemotherapy agents followed by continued use of the drug alone until disease progression in women with recurrent, platinum-sensitive ovarian cancer.
The study met its primary endpoint of extending progression free survival compared to chemotherapy alone.
The results from this trial build on findings from two previous phase III studies (GOG 0218 and ICON7) in women with newly-diagnosed ovarian cancer.
Both of these studies showed that front-line Avastin in combination with standard chemotherapy regimens, followed by the continued use of Avastin alone, significantly increased progression-free survival.
Hal Barron, chief medical officer at Roche, said: “We are very pleased with the results of the OCEANS study, as women with ovarian cancer need new treatment options.
“Avastin has now demonstrated a significant improvement in PFS in ovarian cancer in three large phase III studies and we are looking forward to sharing the data at an upcoming medical meeting.”
Currently, treatment options for women with the disease are limited to surgery and chemotherapy.
Ben Adams
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