Bevacizumab for Ovarian Cancer Approved in EU

Zosia Chustecka

Disclosures

December 23, 2011

December 23, 2011 — Bevacizumab (Avastin, Roche) has been approved for a new indication, newly diagnosed ovarian cancer, by the European Commission. The drug is already marketed for several other cancers.

The new EU approval is for use of bevacizumab as first-line treatment together with standard chemotherapy (carboplatin and paclitaxel) in women with advanced cancer. It is based on data from 2 clinical trials (GOG0218 and ICON-7) that found women who had bevacizumab added to chemotherapy and then continued to receive bevacizumab alone have significantly improved progression-free survival compared with those who received chemotherapy alone.

Updated results from the ICON-7 (International Collaborative Ovarian Neoplasm) trial were reported at this year's annual meeting of the American Society of Clinical Oncology (ASCO) and showed, at a median follow-up of 28 months, progression-free survival of 19.8 months in the bevacizumab group compared with 17.4 months with chemotherapy alone (hazard ratio, 0.87; P = .039). There was also a trend toward improved overall survival, but this did not reach statistical significance; these study patients continue to be followed, and a final analysis has not yet been completed. ASCO highlighted these results as one of the "major clinical cancer advances" of 2011 in its recent annual report.

"Today's approval of Avastin marks the first major treatment advance in newly diagnosed ovarian cancer in 15 years," commented Hal Barron, MD, chief medical officer and head of global product development at Roche.

Bevacizumab has also been studied in recurrent ovarian cancer, and the OCEANS (Ovarian Cancer Evaluation of Avastin and Safety) trial showed significant improvement in progression-free survival when the targeted drug was added to chemotherapy in this setting. Those results were also presented at the ASCO annual meeting and were highlighted as a major advance in the annual report. Recurrent ovarian cancer could be another potential new indication for the drug.

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