Advisors to the European Medicines Agency have backed Roche’s blockbuster Avastin for the most difficult to treat form of ovarian cancer.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended that the European Commission approve the use of Avastin (bevacizumab) in combination with chemotherapy as a treatment for women with ovarian cancer that is resistant to platinum-containing chemotherapy. The positive opinion is based on a Phase III study showing that the addition of Avastin to chemotherapy reduced the risk of disease worsening or death by 62%.
The big-selling drug is already approved in Europe for ovarian cancer, among many other cancers, such as breast, colorectal, non-small cell lung and kidney. Of the 230,000 women diagnosed worldwide each year many will have advanced ovarian cancer that will return after initial treatment, Roche noted, and chief medical officer Sandra Horning noted that women with platinum-resistant ovarian cancer “have limited medicines available for their difficult disease”.
She added that getting the label expansion “would be an important step in helping these women live longer without their disease progressing