Thursday, May 7, 2009

"Trouble for Temodar?" -- An Alert Commenter Gives Us A Tip!


Thanks to a keen-eyed anonymous commenter, below -- we learned about a new FDA approval in Temodar's specific cancer-fighting arena (an arena that's seen no new drug candidate approved in ten years' time): glioblastoma, the most aggressive form of brain cancer. [I was entirely off the grid yesterday -- so it's fabulous to have so-many helpful "extra eyes" out there.]

Cutting to the chase, then -- Roche/Genentech's Avastin was just granted accelerated approval to treat glioblastoma, after the market closed last night. Avastin (bevacizumab) is a "recombinant humanized monoclonal IgG1 antibody that binds to and inhibits the biologic activity of human vascular endothelial growth factor (VEGF) in in vitro and in vivo assay systems", according to Genentech's FDA-approved prescribing information (PDF file). According to FiercePharma, now:

. . . .it's big enough to push sales up by a half-billion or so. In 2008, the drug brought in some $4.61 billion globally. And it's another step toward Roche's goal of $7 billion to $8 billion in Avastin revenues by 2011. . . .

It is certain that at least some of that $500 million a year increase will be at the expense of Temodar (temozolomide) sales. Add this news to the brewing patent litigation/potential "at risk" generics launches, and there's clearly some "Trouble for Temodar" ahead.

While this is potentially good news for brain cancer sufferers -- I should note that Avastin failed to meet a colon-cancer trial endpoint, in April 2009. In any event, it seems it just keeps on rainin' in Kenilworth.

4 comments:

Anonymous said...

So Frank over on Yahoo says that all protocols now combine Avastin with Temo. Well, that's not true. Standard of care currently is Surgery +/- radiation and then Temo. Use of Avastin is a new indication, not previously approved by FDA. So...if anyone was using for Glio then it was an off-label use....that is a 'no-no' and insurance companies would pay for it.

Add to that, if it is now part of all protocols, then why is S/P currently running a clinical trial to analyze it?

Just a few thoughts....

Anonymous said...

and I quote "actually most of the protocols being followed in onc today use combos of all of these therapies in cycles including Avastin and Temodar! "


I wonder if that is how ol'Frankie did his sales job...off-label use.

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