Drug companies stop recruiting for cancer drug test after deaths
PAUL ELIAS
AP via Miami Herald reg Tue Feb 14 200
SAN FRANCISCO - Biotechnology giant Genentech Inc. and its majority stockholder Roche Holding AG said they temporarily halted recruiting volunteers for a large human test of the blockbuster cancer drug Avastin after more patients than expected died.

The deaths occurred among colon cancer patients taking Avastin with a chemotherapy regimen called XELOX. Since the test was started in December 2004, seven patients taking that combination died, four of them suddenly, Roche said in a press release Monday.

“An occurrence of sudden deaths, especially in three younger patients, was noted,” Roche said, adding that the temporary suspension would allow “a full safety assessment.”

Those seven deaths compare to four deaths in another arm of the study that combined Avastin with a different chemotherapy called FOLFOX.

About 2,000 of the 3,450 patients planned for the test already receiving one of three combinations of Avastin and the chemotherapy regimens will continue to receive their drugs. The rest of the volunteers won’t be enrolled for at least 60 days while the companies try to find what caused the deaths.

The test is designed to see if Avastin can safely be used to prevent colon cancer from recurring in patients in remission. The Food and Drug Administration approved Avastin for patients with advanced colon cancer in 2004 and the drug accounted for $1.1 billion in sales for Genentech last year. Basel, Switzerland-based Roche owns sales rights in Europe, where it was approved last year.
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