Avastin story in breast cancer not over yet

After two days of testimony, an FDA advisory panel has decided -- again -- that Avastin should no longer be approved to treat metastatic breast cancer. The panel listened to patients who said the drug was extending their lives, doctors who said the same, experts from Genentech who went over the results of the studies once again. But the panel also listened to experts and patient advocates who said the risks of the drugs were too high, especially when follow-up studies show no survival advantage and a marginal delay in tumor progression. Nearly a year ago, an advisory committee, comprised of many of the same experts who voted yesterday, recommended pulling Avastin's indication in breast cancer, saying follow-up studies did not confirm results showed in the original study that led to accelerated approval. In December, the FDA agreed with that recommendation. However, at the appeal of the drug maker, Genentech, the FDA held a first-of-its-kind meeting to hear why the drug should still be used in metastatic breast cancer. The issue is that the drug may help some women, some of whom attended and spoke at the FDA hearing, but there is no real evidence to show that it is truly Avastin that is prolonging their lives. There also doesn't appear to be any evidence that a particular subgroup does better on the drug. However, Genentech will continue testing it in breast cancer to look for a biomarker that may identify patients who would respond to the drug. But those study results won't be available for another few years, and the FDA panel was not too keen on extending the approval status until then. "Clearly we should not be in this position so many years later after the first announcement that Avastin is effective in breast cancer. This has been going on for almost seven years; that's too long," says Len Lichtenfeld, MD, deputy chief medical officer of the American Cancer Society. "What could we have done differently to avoid this situation?"After talking with a few people (including Dr. Len and patient advocates), reading several news articles and patient blogs, and following two days of Twitter feeds and side conversations, here are some important things I felt should be mentioned:• A final decision hasn't been made yet. Whether or not the FDA pulls Avastin's indication lies with FDA Commissioner Margaret Hamburg. With a unanimous vote, though, it appears highly likely she will side with the advisory panel. The FDA will take public comments, as well as information from the Center for Drug Evaluation and Research and Genentech until July 28. • Until a decision is made, Avastin is still approved for metastatic breast cancer. Insurance and Medicare should cover it, and likely will. The FDA decision, when it comes, does not affect CMS, Don McLeod, a spokesman for the Centers for Medicare and Medicaid (CMS), told Reuters on Thursday, "The drug will still be on the market, doctors will still be prescribing it, and we will continue to pay for it."• If it is withdrawn, Avastin will likely still be available to breast cancer patients through off-label use, however, whether it will be covered under Medicare and insurance remains to be seen. Avastin costs about $88,000 per year. (Genentech has capped annual spending on the drug to $57,000 per year for patients with incomes below $100,000.) • Another independent panel of experts from the National Comprehensive Cancer Network also agreed on the use of Avastin in metastatic breast cancer – but it was in support of using Avastin. This also creates a quagmire. As Dr. Len says, "How can one group of experts look at the evidence and say this is basically of no value to women with breast cancer, when a very qualified group of experts who treat women with breast cancer feel exactly the opposite. I don't think this is over." Insurance companies and Medicare also look to this group when deciding coverage.• Avastin's use and indication for colon, lung, brain and pancreatic remain unchanged. The FDA's decision will have no impact for patients receiving Avastin for these types of cancers. As you can see the implications and angles to the saga are never-ending, and it won't be ending any time soon. Stay tuned.For the backstory of the Avastin saga, read "Hurdles on the Faster Track."