Genentech/Roche's Avastin wins unanimous FDA panel backing for glioblastoma

A US Food and Drug Administration advisory panel has voted by 10 to zero to recommend approval of biotechnology major Genentech and Swiss parent  Roche's cancer drug Avastin (bevacizumab) for previously-treated  patients with glioblastoma multiforme, an incurable form of brain  cancer.

The decision came after earlier suggestions that reviewers were unsure  the clinical evidence of significant tumor shrinkage was sufficient to  grant accelerated approval of the drug. Roche shares ended the day  (March 31) up 3.3% at 156.20 Swiss francs on the Zurich stock exchange.

Avastin, which is currently cleared for the treatment of advanced colon,  breast and certain lung cancers, generated global sales of 5.21 billion  francs  ($4.52 billion) for Roche last year. The additional indication  is not expected to add hugely to turnover, with Deutsche Bank analyst  Mark Schoenebaum, quoted by Bloomberg, estimating a figure of $200.0  annually. Around 10,000 Americans are diagnosed with glioblastoma  multiforme each year, according to Roche, which noted that a global  Phase III trial evaluating Avastin in newly-diagnosed patients will be  initiated later this year. A final FDA ruling on the drug is expected  by May 5.