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New Label on Genentech (RHHBY)'s Avastin Warns of Infertility

10/5/2011 7:54:00 AM

By Ron Leuty, Reporter - San Francisco Business Times

The world’s best-selling cancer drug, Genentech Inc.’s Avastin, now carries a warning about increased risk of infertility in premenopausal women.

The Food and Drug Administration said Avastin’s label as of Sept. 30 includes the new warning regarding “ovarian failure.” Data suggest that some women with the potential of bearing children may become infertile as a result of Avastin and should talk to their doctor before starting treatment, the FDA said.

The new label also lists a degenerative jawbone condition as an adverse reaction, along with the risk of blood clots in the veins and the risk of bleeding in metastatic colorectal cancer patients receiving anti-clotting therapy after an initial blood clot while receiving Avastin.

Both South San Francisco-based Genentech and the FDA said the new information is part of a routine label update.

Avastin has been at the center of a national debate about its conditional approval for women with metastatic breast cancer. FDA Commissioner Margaret Hamburg is weighing an advisory committee's recommendation this summer to revoke that approval because, they said, the risks of the $80,000-a-year drug outweigh the benefits those women live longer without the disease progressing.

The label change is for all cancer types for which Avastin is approved — metastatic breast cancer, and types of non-small cell lung cancer, brain cancer, metastatic colorectal cancer and metastatic renal cell carcinoma — Genentech spokeswoman Charlotte Arnold said.

While Avastin was in preclinical studies — years before it was first approved as a first-line treatment for metastatic colorectal cancer in 2004 — Genentech researchers identified ovarian failure as a possible side effect, Arnold said. Genentech, now a unit of Swiss drug maker Roche, agreed at the time Avastin was initially approved to study the infertility issue further as part of another Phase III study, data from which was used to make this labeling change.

Genentech said it also will issue a letter to health-care professionals about the risk of ovarian failure that is based on that failed study in early-stage colon cancer.

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