Roche has garnered a new indication for Avastin from US regulators, this time in combination with chemotherapy for the treatment of women with platinum-resistant, recurrent ovarian cancer.
The approval from the US Food and Drug Administration was based on results from the Phase III AURELIA study that showed Avastin (bevacizumab) plus chemotherapy reduced the risk of disease worsening or death by 62% compared to women who received chemotherapy alone. Roche chief medical officer Sandra Horning noted that it is “the first new treatment option for women with this difficult-to-treat type of ovarian cancer in more than 15 years”.
It is also the sixth indication for Avastin to get approval from the agency as the blockbuster is already available for colon, lung, kidney and cervical cancers as well as glioblastoma. The green light will boost the already-substantial sales of the drug which rose 6% in the third quarter to 1.65 billion francs; it was approved in Europe for ovarian cancer in August.
