Roche's (RHHBY) blockbuster cancer drug, Avastin, is up for review by the U.S. Food and Drug Administration next month. If the FDA follows its advisory panel's recommendation from last month, it may revoke its approval of Avastin for the treatment of advanced breast cancer.

Avastin -- which has also been approved for metastatic colorectal cancer, non-small cell lung cancer, metastatic kidney cancer, and glioblastoma (brain tumor) -- fights cancer by starving the tumor. It blocks a protein called VEGF, which plays an important part in the formation of blood vessels that provides a tumor with the oxygen and nutrients it needs to survive and spread. The world's best selling cancer drug had nearly $6 billion in sales last year, and analysts say it stands to lose about $1 billion if the breast cancer indication is yanked.

The approval for breast cancer was controversial at the time because the FDA went against the recommendation of its advisory panel. The panel objected because in the initial trial, Avastin increased progression-free survival by 5.5 months without actually increasing life expectancy. The drug was approved under an accelerated approval program, and the company was required to run more studies.

Last month, the FDA's Oncologic Drugs Advisory Committee sifted through data from two subsequent studies. These showed that progression-free survival time ranged from about one month to nearly three months -- even less than the original study -- without extending patients' overall survival. Further, with known risks such as gastrointestinal perforations, bleeding and blood clots, the risk-benefit may not be favorable, the panel said. The panel voted 12 to one to remove the advanced breast cancer indication from Avastin's U.S. label.

Roche doesn't agree, saying the studies showed the drug reduced the risk of progression or death by 31% to 52%. The agency is set to decide the matter by Sept. 17.

On Monday, Rob Stein of the Washington Post noted cost considerations may play a part in the FDA's decision:
The debate over Avastin, prescribed to about 17,500 women with breast cancer a year, has become entangled in the politically explosive struggle over medical spending and effectiveness that flared during the battle over health-care reform: How should the government balance protecting patients and controlling costs without restricting access to cutting-edge, and often costly, treatments?
He adds: "The FDA is not supposed to consider costs in its decisions, but if the agency rescinds approval, insurers are likely to stop paying for treatment." Doctors are allowed to prescribe treatment for off-label uses, so they may continue to use Avastin to treat breast cancer, even if the FDA revokes the approval. Whether or not insurers would approve payment is a different story, considering that Avastin is a $50,000 plus a year drug.

Indeed, most agree the FDA shouldn't consider costs when approving drugs -- drugs that work. But should an ineffective remedy -- as three studies have suggested in Avastin's case -- become a burden on the system?

Perhaps the problem doesn't lie in health care reform, as Stein suggests, but in the accelerated approval process, where a company must follow-up with further studies. Under the FDA's rules, if a drug proves less effective than initially thought, the FDA can revoke its accelerated approval.

In practical terms, however, once a drug has been approved and used, especially in advanced cancer, it's difficult to yank the approval -- as the FDA now finds. Patient groups and pharmaceutical lobbying come into play, naturally. In addition, opportunistic members of Congress have also stepped in to write politically charged protest letters (quoted in the Post article) defending Avastin. Meanwhile, as the New York Times mentions, citing a Government Accountability Office report on the program, the FDA has yet to revoke an approval granted under the program.

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