Switzerland-based Roche has received approval from the US Food and Drug Administration (FDA) for its Avastin (bevacizumab), in combination with paclitaxel and cisplatin or paclitaxel and topotecan, to treat women with persistent, recurrent or metastatic carcinoma of the cervix.
Avastin is the first biologic medicine approved in combination with chemotherapy, which will help women to live longer than with chemotherapy alone, according to Roche.
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Roche chief medical officer and global product development head Dr Sandra Horning 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."
Avastin was approved in the US to treat five distinct tumour types, with the latest approval for advanced cervical cancer.
The approval was granted to treat advanced cervical cancer based on the GOG-0240 study.
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By GlobalDataThe GOG-0240 independent and National Cancer Institute (NCI)-sponsored study of the Gynecologic Oncology Group (GOG), assessed the efficacy and safety profile of Avastin plus chemotherapy (paclitaxel and cisplatin or paclitaxel and topotecan) in women with persistent, recurrent or metastatic cervical cancer.
Roche noted that the study met its primary end-point of improving overall survival with a statistically significant 26% reduction in the risk of death for women who received Avastin plus chemotherapy, compared with those who received chemotherapy alone.
In 2004, the company first received approval for Avastin in the US to treat colorectal cancer.
