Roche's Genentech unit announced Thursday that the FDA extended the indication for Avastin (bevacizumab) to include use in combination with paclitaxel and cisplatin, or with paclitaxel and topotecan, for patients with persistent, recurrent or metastatic cervical cancer. Sandra Horning, global head of oncology at Genentech, remarked that "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."
The US regulator had granted priority review for Roche's application, which was supported by data from the Phase III GOG-0240 trial. In the study, which involved 452 women with persistent, recurrent or metastatic cervical cancer receiving one of two standard chemotherapy regimens, with or without Avastin, patients treated with Avastin plus chemotherapy had a significant 26-percent reduced risk of death, compared to those administered chemotherapy alone. Further, patients in the combination treatment arm achieved a significant objective response rate of 45 percent, compared to 34 percent for women who received only chemotherapy.
The latest approval extends Avastin's US indications to five cancer types, the other four being colorectal cancer, non-small-cell lung cancer, glioblastoma and renal cell carcinoma. In July, the FDA awarded priority review to Roche's application to market Avastin plus chemotherapy for the treatment of recurrent, platinum-resistant ovarian cancer.
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