Will FDA fast-track Avastin for brain cancer?

We've heard an analyst describe Genentech's Avastin as "a pipeline in one drug." Apparently Genentech thinks so, too. The drugmaker is asking the FDA for yet another approval for the cancer med, this time as a remedy for the most aggressive form of brain cancer. And Genentech has requested that the FDA fast-track the app so that Avastin could obtain provisional approval based on some preliminary data. That would get the drug to more patients with glioblastoma--the type of cancer Sen. Edward Kennedy has--as quickly as possible.

The application is based on evidence from a mid-stage study showing that patients whose previous treatment failed saw increased survival time with Avastin as a second-line treatment. The Avastin patients also went longer than expected without progression of their disease. But it wasn't a double-blind study directly comparing Avastin's effectiveness against another cancer treatment or a placebo. That kind of study will be launched next year, and it will look at Avastin as part of the first-line treatment for glioblastoma patients.

No word yet on whether the FDA has accepted the app for the six-month fast-track review process.

As you know, Avastin is already approved for marketing to colon, lung and breast cancer patients. Last year, it added $2.3 billion to Genentech's sales coffers, and so far this year, it's chalked up some $2 billion in sales.

- read the Genentech release
- see the WSJ Health Blog's take

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