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FDA PANEL WANTS RESUMPTION OF BREAST-CANCER DRUG STUDY

SHARE FDA PANEL WANTS RESUMPTION OF BREAST-CANCER DRUG STUDY

A study to see if the potent drug tamoxifen can prevent breast cancer in healthy women should be resumed immediately, despite fears that it causes uterine cancer, a federal panel says.

But because of that newly discovered risk, researchers also should use the tamoxifen study to discover what gynecological tests best detect uterine cancer, the Food and Drug Administration advisory committee said Tuesday.Earlier research showed Tamoxifen reduces the recurrence of breast cancer by up to 50 percent.

Now doctors and patients are clinging to the drug as the best hope to prevent breast cancer in high-risk women, instead of just treating the disease, which strikes 180,000 Americans every year.

Some 16,000 healthy but high-risk women were to test either tamoxifen or a placebo for five years. Almost 11,000 have enrolled so far in the study, being run by the University of Pittsburgh.

But Pittsburgh researchers, already plagued by a scandal of falsified data in another breast cancer study, didn't immediately warn the women that tamoxifen increases the risk of uterine cancer and that four volunteers have died of the disease so far.

The National Cancer Institute, which is funding the $68 million tamoxifen trial, suspended the study in April and the FDA issued a strong warning about the uterine cancer risk.

The FDA said Tuesday that its advisory committee's ruling means the agency won't block resumption, although NCI will make the final decision.