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www.fdanews.com/articles/170790-roches-avastin-for-advanced-cervical-cancer-wins-eu-nod

Roche's Avastin for Advanced Cervical Cancer Wins EU Nod

April 14, 2015

The European Commission has approved Roche's Avastin plus chemotherapy for women with persistent, recurrent or metastatic cervical cancer, the company said last week.

Avastin (bevacizumab) is indicated in combination with standard chemotherapy — either paclitaxel and cisplatin or paclitaxel and topotecan in patients who cannot receive platinum therapy.

The approval was based on the pivotal GOG-0240 study, which showed a 26 percent drop in the risk of death in women getting the Avastin cocktail. On average, women taking Avastin plus chemotherapy lived four months longer than women who didn’t get the combination — 16.8 months versus 12.9 months.

The drug was approved in the U.S. based on the same data in August 2014, and is available in seven other countries worldwide. — Jonathon Shacat