Avastin sales are a dangerous comparison because of the remarkably high price of the drug. But on the other hand, it is interesting to look at as a 'widely-tried drug.' Metastatic colon cancer (I think that's the principal indication for Avastin.) Is a big market in itself, but Avastin is being tried out (the hot term is 'investigator-sponsored phase 2')against everything. Once Azixa is on the market, I expect that it will be tried out against at least everything that has a risk of metastasizing to the brain.
You never want to be turned down by FDA, but as I look at the results so far I'm half convinced that the company ought to apply for licensing sooner rather than later. One of the stated reasons for not doing a phase 3 for salvage treatment of GBM with and without Avastin is the high cost of Avastin. The consistent acceptable results of studies so far suggest to me a good probability of getting to market 1-2 years earlier that way than by trying to come in as a primary drug. While that wouldn't be a good deal if the only actual use of Azixa was for salvage in GBM, the value of letting oncologists try the drug for everything that much sooner would seem to justify it.
Avastin is also sold by one of the best sales forces out there. The reason Oncologists try Avastin 'for everything' is due to their past success with the drug and the overwhelming amount of trial data.They will not try a drug in mutliple settings with little data/success in their own patient population. Reimbursement is also a rapidly changing environment and docs will not try a new drug where the foresee a potential for a lack of reimbursement - off label for example. While you make a great point, I think your suggestion is big risk - better to wait and be sure with solid data/indication, than push and be disappointed? It wouldn't help to create a small niche for the drug if it does have potential for earlier lines in the future.
Look at Vectibix and the PAACE trial - had it paid off it would've have changed things drastically for patients, treatment of mCRC, the success of the drug, the success at the time of Amgen etc., etc. but was viewed by many as greedy and did nothing for the success of any of the above. Avastin was included in that trial and received no negative press.
I like the outlook for the company as a longer term investment and support extreme caution in this area as being a solid decision by those making such decisions. The more credible they can make the trials first time around, the better the overall big picture in the future. Just my .02.
I think that we'll be hearing of more indications like breast cancer where Avastin is a whole lot better at treating the chart than the patient. You can say that grabbing market before those second thoughts come out is a function of a great sales force. I know that Genentech/Roche are very politically skillful, which lets them get away with some marginal practices in off-label not-quite-promotion. Whatever.
The principal sales target for Azixa is "big 4" cancers metastatic to the brain. A phase 3 aimed at those is economically infeasible, so the game is to get the drug approved for Something and maneuver from there.