Roche’s Avastin gets FDA approval for use with chemotherapy in cervical cancer

15 August 2014
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Swiss drug major Roche (ROG: SIX) has received approval from the US Food and Drug Administration for its blockbuster cancer drug Avastin (bevacizumab) in combination with paclitaxel and cisplatin or paclitaxel and topotecan for the treatment of persistent, recurrent or metastatic carcinoma of the cervix.

Sandra Horning, chief medical officer and head of global product development at Roche, said: “With this approval, women with advanced cervical cancer now have the option of Avastin plus chemotherapy to help them live longer than with chemotherapy alone. Cervical cancer is most commonly diagnosed in women between the ages of 35 and 44, and until today, chemotherapy was the only approved treatment option for women whose cancer recurred, persisted or spread.”

This is the fifth tumor type for which Avastin has been approved in the USA. The study on cervical cancer met its primary endpoint of improving overall survival with a statistically significant 26% reduction in the risk of death for women who received Avastin and chemotherapy, compared to those who received chemotherapy alone. In addition to this, the Avastin plus chemotherapy arm had a significantly higher rate of tumor shrinkage compared to chemotherapy (45% versus 34%).

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