Roche receives EC approval for treatment of platinum-sensitive ovarian cancer

Comtex News Network

Nov 02, 2012 (Datamonitor via COMTEX) -- Roche Holding AG has received European Commission, or EC, approval for Avastin in combination with standard chemotherapy, carboplatin and gemcitabine, as a treatment for women with first recurrence of platinum-sensitive ovarian cancer.

Avastin is already approved by the EC as a front-line (first-line following surgery) treatment for women with advanced ovarian cancer. The additional approval of the medicine is important for women with ovarian cancer who are now able to receive Avastin in combination with chemotherapy once their disease returns.

Patients are said to have 'platinum-sensitive' disease if their ovarian cancer returns more than 6 months after completion of platinum-based chemotherapy.

This approval was based on data from the Phase III OCEANS study which showed that women with recurrent, platinum-sensitive ovarian cancer who received Avastin in combination with chemotherapy lived significantly longer without their disease getting worse (progression-free survival) compared to those who received chemotherapy alone (HR=0.48; p<0.0001).

Ovarian cancer is associated with high concentrations of vascular endothelial growth factor (VEGF), a protein associated with tumor growth and spread. Avastin is an antibody that precisely targets and inhibits VEGF for tumor control, the company said.

"This EU approval of Avastin is an important advance for women with recurrent ovarian cancer because very few treatment advances have been made in over a decade for patients with the disease," said Hal Barron, Roche's chief medical officer and head of global product development.

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