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FDA Wants More Information From Genentech

Genentech Inc. must provide further proof of safety and efficacy to the Food and Drug Administration before the agency approves use of the company’s cancer drug, Avastin, in combination with chemotherapy for first-line metastatic breast cancer.

The South San Francisco-based company said this year that it expects to begin producing Avastin at its Oceanside facility, which employs around 400, in 2007.

The company said it will not reapply with the FDA to market Avastin for breast cancer with chemotherapy until mid-2007.

Genentech did not immediately return a phone inquiry as to whether the resubmission will affect the Oceanside production plans.

Avastin is already approved for late-stage colorectal cancer and brought in $1.13 billion in sales in 2005.

“We are disappointed that this will cause a delay in the review of our application as there is an unmet medical need for women with metastatic breast cancer,” the company’s senior vice president of development and chief medical officer, Hal Barron, said in a press release Sept. 11.

The company is testing Avastin to treat 25 types of cancer. Two clinical trials for Avastin were called off this year. One tested Avastin’s ability to lower recurrence of colorectal cancer when combined with chemotherapy following surgery.

Testing was resumed once scientists from an external review board determined the death rate during the study was not unusual.

The other trial for Avastin explored the drug’s potential for healing pancreatic cancer when combined with chemotherapy. It was called off in June after a review board determined further studies wouldn’t provide evidence that the drug is effective for that use.

, Katie Weeks

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