Thursday, February 28, 2008

Biotechnology February: Genentech Avastin Decision

I'll read just about any biotechnology news that comes my way, but I pay the most attention to Amgen (AMGN), Anesiva (ANSV), Biogen-Idec (BIIB), Celgene (CELG), Genentech (DNA), Dendreon (DNDN), Gilead (GILD), and Onyx Pharmaceuticals (ONXX). I am gradually building a biotech portfolio and currently own Anesiva, Biogen-Idec, Celgene, Dendreon, and Gilead. I always take notes and post summaries of these companies' quarterly analyst conferences, which you can access through my analyst conference summary page.

For this blog I thought I'd try something a bit different today. Stock prices are mostly determined by an individual company's performance. Nevertheless, there is news that can impact an entire industry, like changes in how much national governments are willing to pay for drugs. There are also times when an event changes the competitive landscape, as when a notably better treatment is introduced for a disease.

This month we have some surprising news on the FDA drug approval front. "Accelerated" approval was granted to Genentech for "Avastin® (bevacizumab), in combination with paclitaxel chemotherapy, for the treatment of patients who have not received chemotherapy for their metastatic HER2-negative breast cancer." Lets just call it a breast cancer approval for now.

The reason this is not a run-of-the-mill approval is two-fold. First, the FDA advisory panel had recommended against the approval by a 5 to 4 vote back in December 2007. The data was deemed insufficient to establish a favorable risk/benefit analysis for the use of Avastin.

I don't have statistics on it, but the FDA has tended to have a higher bar than its advisory panels. So a vote to disallow a drug that was recommended by a panel would not be as big of a surprise. For instance, Dendreon's Provenge for prostate cancer was recommended by a panel but then denied pending further study ("given an approvable letter", is the lingo).

The FDA had already given Avastin for breast cancer an approvable letter back in August 2007 [See press release]. So this current round was a re-submission. And what probably made the difference was additional data from additional trials, and the possibility of getting good data from ongoing trails. data by the FDA will be required for the accelerated approval to be converted into a full approval. "As a part of our commitment to fully evaluate Avastin in breast cancer, Genentech will also submit data to the FDA from three additional randomized trials that are either ongoing or planned." And if the data is unconvincing, the FDA can pull the tentative, accelerated approval.

So all that is interesting, but the real news is that this decision appears to mark a change in FDA policy. A lowering of the bar for cancer drugs.

In the past the gold standard for treatments has been the extension of patients' lives. Or more coldly, increasing the time until death. Improving the quality of life is another plus. Any side effects are weighed against the benefits. Avastin for breast cancer does not appear to prolong patient's lives, nor does it provide for a better quality of life. Instead, Avastin was demonstrated to slow the growth of tumors. You might think that would cause patients to live longer, but in the case of Avastin any lengthening of life has not been shown to be statistically significant in the clinical trials.

There is an argument that if something shrinks or slows the growth of cancers, it has a place beside other therapies. Clearly the FDA bought that argument.

A lot of drugs will be reviewed to see if they might meet this new criteria. Until some are put forward, we won't know whether Avastin for metastatic HER2-negative breast cancer is an exception to the rule, or the new rule.

It is possible that the FDA is reacting to negative publicity on the Provenge decision. A lot of prostate cancer patients want to try Provenge and have been pressuring Congress to get that opportunity sooner rather than later.

It is not easy being the FDA. People want you to make the right decision all the time, but what is right is open to dispute. Drugs go on the market that later prove to have unforeseen side effects and everyone wants the FDA to tighten up on approvals. But desperate patients want to grasp at any hope provided to them by the drug companies. Given how complicated medical science is, even though I many disagree with the FDA on a particular decision, I think they are doing a good job overall.

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