The Burrill Report


Avastin, Roche's phenomenally successful advanced cancer medicine, did not help people with early-stage colon cancer alive longer or reduce their risk of relapses when combined with chemotherapy new study data shows.

The disappointing news adds to a pileup of issues eroding sales projections for the drug and adds to pressure on Roche to pursue new cost-cutting measures in the months ahead.

The study, part of a late stage trial of Avastin for early-stage colon cancer patients, compared the efficacy and safety of Avastin plus chemotherapy to chemotherapy alone. The results showed that people receiving chemotherapy along actually fared better than those also taking Avastin.

“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,” says Hal Barron, Roche’s head of global product development and CMO.

Consensus expectations for sales of Avastin in 2014 dropped by 10 percent to $7.7 billion during August, according to EvaluatePharma.

Analyst expectations were depressed in part by news in July that a Food and Drug Administration panel advised the agency to revoke Roche’s right to market Avastin as a treatment for metastatic breast cancer, after trial data available then convinced the panel that the biologic's risks in that indication might outweigh its benefits.

The FDA was due to make a final decision about whether or not to revoke that approval by September 17. It has now extended its review to December 17 in light of new data provide by Roche.

Avastin accounted for $5.9 billion in 2009 sales for Roche, but extending the franchise has proven difficult. In February, a late-stage study of the drug’s utility in tackling stomach cancer turned out a negative result. The Swiss pharmaceutical is also facing increased resistance from government payers for all manner of drugs, including Avastin, which can cost as much as $88,000 annually for a breast cancer treatment regimen.

In response, Roche is reviewing its operations, evaluating where to make operational and staffing cuts. The results of that review are due by the end of this year.


September 23, 2010
http://www.burrillreport.com/article-another_avastin_setback.html