US FDA Advisory Panel likely to focus on increased death risk associated with Roche's Avastin, says Nomura

Although investors are looking for the US Food and Drug Administration's July 20 Advisory Panel to endorse tumor shrinkage (PFS) and not overall survival (OS) as a metric to recommend Swiss drug major Roche's Avastin (bevacizumab), final approval in the initial treatment of late-stage breast cancer (mBC), analysts at Nomura see the trend to increased overall death among patients using Avastin in recent FDA mandated trials (AVADO, interim RIBBON1).

Avastin was Roche's biggest selling drug in 2009 with turnover of about $5.9 billion in its currently-approved indications. Sanford Bernstein analysts recently projected that Avastin will account for a staggering 25% of Roche's growth between now and 2015, mostly coming from ovarian and breast cancer, and expanding its use in other countries.

Recent Avastin trials that confirmed cancer growth slowdown by one to two months (PFS), but showed no benefit on OS have left drug sector analysts arguing that this result is good enough to warrant full US approval in breast cancer. (Avastin is currently only provisionally approved in mBC, pending full results of AVADO and RIBBON I. Final survival data from RIBBON I remain unpublished despite an FDA submission in November 2009.)