In the news this week, a Food and Drug Administration advisory panel is recommending that the drug Avastin (bevacizumab), the best selling product of Roche (developed by its Genentech unit) has its 2008 approval for advanced breast cancer treatment revoked. Taking back a drug approval is something the FDA rarely does. Avastin is of course a drug of high interest as a candidate NF2 therapy: following a Harvard-based clinical trial of the drug published in the New England Journal of Medicine last summer other studies and assessment of Avastin in NF2 have ensued, an area that CTF is currently tracking through our Avastin Survey.
The rationale for revoking Avastin’s breast cancer approval is that while the first clinical trials looked promising, to the point that some hailed Avastin as a ‘miracle’ drug, follow up studies showed that Avastin doesn’t extend women’s lives by a statistically significant amount, a measure that is considered a ‘gold standard’ for cancer drugs. The full picture is yet to emerge – for example, are some patients responding and others are not (perhaps due to genetic differences), giving an overall mixed result? Will Avastin have more effect used in conjunction with another drug (currently being investigated?) Some questions are tougher to answer: if someone’s life is extended by a handful of days or weeks because of Avastin, can we rationalize that out of the picture because it is ‘not statistically significant?’
Regardless, the FDA advisory panel recommendation has the broadest interests of the public in mind. The arena of looking for effective drug treatments is not a venue for miracles, but for careful, thoughtful work. Avastin will continue to be used and assessed in lung cancer and colon cancer and despite the revocation if it comes, in breast cancer too, in the context of clinical trials for those patients with the resources to access the drug. For NF2, we are seeing a glimmer of promise for Avastin as a treatment. While we can’t know what lies ahead, we will continue to track the progress of Avastin trials and support further investigation into its success in treating NF2 and other potential treatments.
