Roche has decided they can’t wait for either a scientific meeting or a journal publication – they’re releasing their clinical trial results now by press release.
Here’s their latest press release on the ‘results’ of their clinical trial of Avastin in ovarian cancer –
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that a phase III study showed the combination of Avastin (bevacizumab) and chemotherapy followed by maintenance use of Avastin increased the time women with advanced ovarian cancer lived without their disease worsening (progression-free survival or PFS) compared to chemotherapy alone. A preliminary assessment of safety noted adverse events previously observed in pivotal trials with Avastin. Data from the study will be submitted for presentation at the 2010 American Society of Clinical Oncology (ASCO) annual meeting, June 4 to 8, 2010.
Note, if you will, the complete absence of any data.
Which means one of two things – either (1) “lived longer” means something like a few weeks, and Roche figures they’d better hurry up and get their little stock bump now before the real results come out in June; or (2) the results are so fantastic that they just couldn’t wait to tell us all. Anyone wanna’ venture a guess as to which it is?
Doesn’t the FDA regulate this sort of stuff?
um, i'm not a medical person, but if the results were really fantastic, wouldn't they say why and back it up with data?
and also, from my side of the fence — "adverse events" with treatments for cancer patients tend to start with barfing and range to dying before anyone thought you would. phfthhhh.
Progression-free survival does not necessarily confer any actual survival advantage. It's not unusual for cancer treatments to lengthen progression-free survival without actually extending patients' lives.
My guess is that Roche has no data on survival at all (note that they never said the women lived longer), only on the proxy status of progression-free survival.
Very good indeed – I use to review medical and legal documents for Merck – they do things for OBVIOUS reasons! Stephanie
Yeah this is pretty fishy. In fact, journals should hesitate to publish their data, as they have already pre-published it, which is generally not allowed.
To answer your question, yes, the FDA has rules on this. That's why they (Roche) didn't mention the data specifically.
Roche is jumping the gun a bit and making claims for investors. If the data weren't there, they wouldn't mention it, but they need to get the indication approved officially by the FDA before they can publish the data.
They must be feeling pretty confident though or this will blow up on them if they have to retract (from a financial market point of view). I would say that there bigger risk is that they get slapped like Pfizer did for off label marketing. That was a big fine for sure, and their relationship with the FDA is likely very tainted right now. Not a risk that a pharma company should be taking these days.
You call it fishy now, but when they get permission you will be able to review the data, and hopefully you will find that their "confidence" was justified. For the patients who are now very hopeful that the data is good, I would hope it is so.
um, i’m not a medical person, but if the results were really fantastic, wouldn’t they say why and back it up with data?and also, from my side of the fence — “adverse events” with treatments for cancer patients tend to start with barfing and range to dying before anyone thought you would. phfthhhh.
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Yeah this is pretty fishy. In fact, journals should hesitate to publish their data, as they have already pre-published it, which is generally not allowed.