Avastin bevacizumab regulatory update

Chugai said it submitted a regulatory application to Japan's Ministry of Health, Labor and Welfare (MHLW) to expand the label of Avastin bevacizumab to include treatment of ovarian, fallopian tube or primary peritoneal cancer. In Japan, Avastin is approved to treat unresectable advanced or recurrent colorectal cancer, unresectable advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) and inoperable or recurrent breast cancer. Last month, Chugai submitted an application to the MHLW to expand the drug's label to include recurrent glioblastoma (see BioCentury, Sept. 24).

Separately, the Scottish Medicines Consortium (SMC) recommended against the use of Avastin in combination with carboplatin and paclitaxel for first-line treatment of advanced epithelial, fallopian tube or primary peritoneal cancer. The agency said that while Avastin plus chemotherapy significantly improved progression-free survival (PFS) in 2 Phase III trials compared with chemotherapy alone, Roche's economic analysis was based on an unlicensed dose of Avastin. The agency said the sensitivity analyses using the licensed dose included a justification of the drug's treatment cost in relation to its health benefits that was not sufficient. SMC also said Roche did submit a sufficiently robust economic analysis. ...