The U.S. Food and Drug Administration (FDA) has approved Genentech’s 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.
Cervical cancer affects more than 12,000 women in the United Sates every year.
Early and advanced states of this malignancy have strikingly different associated survival rates, with 9 out of 10 women surviving for five years following diagnosis of early stage disease, with these rates dropping to only 1 in 6, when the disease has already metastasized to other parts of the body.
Avastin is a biological antibody, delivered intravenously, that specifically binds to the vascular endothelial growth factor (VEGF) protein. VEGF is a key player in the tumor lifecycle, allowing it to grow and develop through the formation of new blood vessels, that are manipulated by the cancer itself to maintain its own supply of oxygen and nutrients. By binding to VEGF, Avastin can block the tumor blood supply, affecting its ability to metastasize.
“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,” Sandra Horning, M.D., chief medical officer and head of Global Product Development, said in a Genentech press release. “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 FDA approval will allow Avastin to treat five different tumor types in the U.S. (including colon, lung and kidney cancers), and was based on the promising results of the GOG-0240 study, a National Cancer Institute (NCI)-sponsored study that evaluated 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.
This trial followed 452 women and met its primary endpoint of improving overall survival, demonstrating a significant 26% reduction in the risk of death for women who received Avastin plus chemotherapy versus those who received chemotherapy alone.
Furthermore, women who received Avastin plus chemotherapy had a significantly higher rate (45%) of tumor shrinkage than women who received chemotherapy alone (34%).
Genentech Access Solutions offers patient assistance for people taking Avastin who meet certain eligibility criteria. For additional information, you can call (866) 4ACCESS/(866) 422-2377 or visit their website here.