Avastin approved in Europe for ovarian cancer
EUROPE—On December 23, the European Commission approved the use of bevacizumab (Avastin; Roche) for a new indication: newly-diagnosed ovarian cancer. The drug is currently marketed for several other types of cancer; however, the U.S. Food and Drug Administration (FDA) recently revoked approval of Avastin for breast cancer, citing that it is neither safe nor effective for that type of cancer.
The European Commission’s approval is for use of Avastin as a first-line treatment together with standard chemotherapy, which includes carboplatin and paclitaxel, in women with advanced ovarian cancer. The approval is based on data from two clinical trials (ICON-7 and GOG 0218); these studies found that women who had Avastin added to their chemotherapy regimen and subsequently received Avastin alone experienced significantly-improved progression-free survival compared with those who received just the standard chemotherapy. (ICON: International Collaborative Ovarian Neoplasm; GOG: Gynecologic Oncology Group.)
Updated results from the ICON-7 trial were reported at the 2011 annual meeting of the American Society of Clinical Oncology (ASCO); at an average follow-up of 28 months, progression-free survival of 19.8 months was found in the Avastin group compared to 17.4 months with chemotherapy alone. A trend toward improved overall survival was found; however, the results wee not clinically significant. Follow-up is ongoing in the study group; thus, a final analysis has not been completed. In its recent annual report, the ASCO highlighted these results as one of the "major clinical cancer advances" of 2011.
"Today's approval of Avastin marks the first major treatment advance in newly diagnosed ovarian cancer in 15 years," noted Hal Barron, MD, chief medical officer and head of global product development at Roche.
Avastin has also been studied in recurrent ovarian cancer, and the Ovarian Cancer Evaluation of Avastin and Safety (OCEANS) trial; the drug was reported to significantly improve progression-free survival when it was added to chemotherapy in this group of patients. Those findings were also presented at the ASCO annual meeting and were stressed as a major advance in the annual report. Recurrent ovarian cancer could be another potential new indication for the drug.
In the United States, Avastin is approved for colon, lung, kidney, and brain cancers. In 2008, Avastin received accelerated approval for metastatic breast cancer under a program that allows drugs for serious diseases to reach the market quickly, subject to further study. In December 2010, the FDA stated that these later studies did not confirm the initial findings that Avastin was effective. The members of the advisory committee reported that the results from clinical trials suggested Avastin was not helping women; however, it was exposing them to potentially serious side effects including hemorrhages, high blood pressure, and gastrointestinal perforations.
The FDA’s focus is on safeguarding the public from imperfect drugs and food contaminants. The European Commission has a much broader scope; it is the executive body of the European Union. The body is responsible for proposing legislation, implementing decisions, upholding the Union's treaties and the general day-to-day running of the Union. With its broader scope, it is possible that the European Commission’s scrutiny of new pharmaceuticals is less thorough than that of the FDA.
Ovarian cancer is the fifth most common cancer among women, and it causes more deaths than any other type of female reproductive cancer. Its cause is unknown; however, older women are at highest risk. About two-thirds of the deaths from ovarian cancer occur in women age 55 and older. About 25% of ovarian cancer deaths occur in women ages 35 - 54.