avastin may affect fertility (may cause premature ovarian failure)

[Lani]

report is in women on FOLFOX with avastin for colon cancer, so may not apply to those on other chemo/targeted combinations for breast cancer

WASHINGTON—Treatment with Roche Holding AG's cancer drug Avastin might affect fertility in some women, the Food and Drug Administration said Tuesday.

The agency said a new warning about the risk of "ovarian failure" was added to Avastin's label and recommended doctors tell women of child-bearing age before they start treatment about the possibility that Avastin can cause ovaries to stop releasing eggs regularly.

Avastin is approved to treat certain types of lung, brain, kidney, colon and breast cancers. However, in the U.S., Roche is fighting to keep the FDA from revoking the approval for breast cancer after clinical studies called into question the product's effectiveness for that type of cancer.

The label update announced Tuesday is separate from a pending decision from the FDA commissioner about whether to strip the approval of Avastin for breast cancer.

The FDA and companies routinely revise drug labels when there are new clinical data or side-effects seen in so-called "postmarketing event reports," or side-effects seen in patients after the drug hits the market.

In a statement, Roche's Genentech unit, which markets Avastin in the U.S., said it "takes patient safety very seriously and consistently reports new safety information about our medicines, collected through clinical trials and in the postmarketing setting" to the FDA. The company said it would send health-care professionals a letter discussing the new labeling changes.

The FDA and the company said there was updated information added in a section of the drug label about blood clots and bleeding risk. The label already warned of the possibility of several types of serious side-effects including fatal bleeding, strokes and heart attacks.

The label also states there have been reports of jaw decay, or osteonecrosis of the jaw. In a statement on the FDA's website, the agency said it isn't clear if Avastin is linked to the development of osteonecrosis.

The information on ovarian failure came from a clinical trial involving the use of Avastin in a study of 179 women with colon cancer who were all being treated with a chemotherapy regimen known as Folfox. About half the women received Avastin in addition to chemotherapy. The study showed 34% of women receiving Avastin experienced ovarian failure, compared to 2% of patients not receiving Avastin. Ovarian function returned in about 20% of the women after treatment with Avastin was stopped.

"Long-term effects of Avastin exposure on fertility are unknown," the FDA said.