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news.Roche has received approval from the US Food and Drug Administration (FDA) for Avastin (bevacizumab) in combination with paclitaxel and cisplatin or paclitaxel and topotecan to treat women with persistent, recurrent or metastatic carcinoma of the cervix.
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With this approval in advanced cervical cancer, Avastin is approved in the US for the treatment of five distinct tumor types.
The FDA approval is based on the GOG-0240 study, which evaluated the efficacy and safety profile of Avastin plus chemotherapy (paclitaxel and cisplatin or paclitaxel and topotecan) in these women.
GOG-0240 is an independent, National Cancer Institute (NCI)-sponsored study of the Gynecologic Oncology Group (GOG).
Roche Global Product Development chief medical officer and head Dr Sandra Horning said with the 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," Horning said.
Data from 452 women showed that the GOG-0240 study met its primary endpoint of improving overall survival (OS) with a statistically significant 26% reduction in the risk of death for women who received Avastin plus chemotherapy compared to those who received chemotherapy alone.
According to the study, women who received Avastin plus chemotherapy had a significantly higher rate of tumor shrinkage (objective response rate, ORR) compared to chemotherapy alone.
Image: The approval of Roche’s Avastin plus chemotherapy from FDA was based on results of the GOG-0240 study. Photo: courtesy of Baitong333/ freedigitalphotos.net.