Roche announced that the U.S. Food and Drug Administration (FDA) approved Avastin (bevacizumab) in combination with paclitaxel and cisplatin or paclitaxel and topotecan for the treatment of women with persistent, recurrent or metastatic carcinoma of the cervix.
“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,” said Sandra Horning, chief medical officer and head of Global Product Development. “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.”
With this approval in advanced cervical cancer, Avastin is approved in the United States to treat five distinct tumor types. The approval in advanced cervical cancer was based on the GOG-0240 study.
GOG-0240 is an independent, National Cancer Institute (NCI)-sponsored study of the Gynecologic Oncology Group (GOG), which 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. Study data from 452 women showed:
- The 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 (median OS: 16.8 months vs. 12.9 months; Hazard Ratio (HR)=0.74, p=0.0132).
- The study showed women who received Avastin plus chemotherapy had a significantly higher rate of tumor shrinkage (objective response rate, ORR) compared to chemotherapy alone (45% [95% CI: 0.39%-0.52%] vs. 34% [95% CI 0.28%-0.40%]).
- Hypertension (high blood pressure) of Grade 2 or higher was significantly more common with Avastin-containing regimens (29% vs. 6%), but no patients discontinued Avastin because of hypertension. Grade 3 or higher thrombosis (blood clots) were significantly increased with the Avastin-containing regimens (8.3% vs. 2.7%). Gastrointestinal-vaginal fistulas (abnormal passage from one part of the body to another) occurred in 8.2% of patients receiving Avastin-containing regimens compared to 0.9% with chemotherapy alone, all of whom had a history of prior pelvic radiation. Patients who develop these fistulas may require additional surgery. Additionally, 1.8% of Avastin treated patients and 1.4% of control patients were reported to have had non-gastrointestinal fistulas in the vaginal, vesical, or female genital tract. Gastrointestinal perforations (a hole in the stomach or intestine) also occurred in 3.2% of Avastin-treated patients, all of whom had a history of prior pelvic radiation.
- There was no increase in treatment-related deaths in the Avastin plus chemotherapy arm as compared to the chemotherapy alone arm.
Date: August 15, 2014