Roche's Avastin Fails in Early-Stage Colon Cancer Study

The top-selling cancer-fighting drug Avastin, which was once believed to have the potential to help treat many cancers, has hit another roadblock in testing. In a recent Phase III study, Avastin failed to improve disease-free survival in early-stage colon cancer patients when administered immediately after surgery, reported its manufacturer, pharmaceutical giant Roche (RHHBY), on Saturday.

Roche, the world's largest maker of cancer drugs, said data from the study showed that adding Avastin to standard chemotherapy for one year after surgery wasn't effective in reducing the risk of relapses. Indeed, the data showed better outcomes for standard chemotherapy alone. While Roche is now evaluating how to proceed in its post-surgery program, it made it clear these results don't affect Avastin's approved indications as a treatment for advanced stages of the disease.

"While we originally hoped the significant survival benefit of Avastin seen in metastatic disease in colorectal cancer would be translated to the early setting, it is becoming increasingly clear that the effects of Avastin are different in the metastatic and early disease settings for patients with colon cancer,'' said Chief Medical Officer Dr. Hal Barron.

Avastin -- which was first approved for metastatic colorectal cancer in 2004, and later for non-small cell lung cancer, metastatic kidney cancer, breast cancer and glioblastoma (brain tumor) -- fights cancer by starving the tumors. It blocks a protein called VEGF, which plays an important part in the formation of blood vessels that provide tumors with the oxygen and nutrients they need to survive and spread.

Billions at Stake for Roche

Swiss pharmaceutical Roche added Avastin to its portfolio when it acquired Genentech last year, and the blockbuster drug and its expansion potential likely factored heavily into the decision to buy the San Francisco-based biotech firm. But since then, Avastin has been dealt several blows, not the least being a Food and Drug Administration advisory panel recommending the FDA revoke its controversial 2008 approval of Avastin as a treatment for breast cancer. The FDA could decide to revoke the approval any day. The FDA was also supposed to decide on Friday whether to approve an additional indication for Avastin as a first-line breast cancer treatment (for patients not previously treated). That decision has been delayed until December.

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As the world's best-selling cancer drug, Avastin recorded nearly $6 billion in sales last year, but if the FDA yanks its approval of Avastin for breast cancer, analysts say the company stands to lose about $1 billion in sales.

Avastin has experienced other setbacks this year, including Great Britain again refusing to approve Avastin for colorectal cancer on the basis of its poor cost-effectiveness, and another late-stage study showing Avastin failed to extend survival in men with advanced prostate cancer, compared to current treatments.

In addition, Roche has experienced setbacks not related to Avastin, such as the FDA's recent rejection of accelerated approval for its other potential breast cancer drug, T-DM1. Meanwhile, Roche has said pricing pressures due to U.S. health care reform and austerity programs in Europe and the U.S. have hurt its margins and sales. So it's no wonder the pharmaceutical giant initiated a major cost-cutting plan earlier this month. It's also no wonder Roche stock has dropped nearly 20% year-to-date.