FDA approvesnew breast cancer drug
By Steve Mitchell,
UPI Medicine and Health Correspondent
WASHINGTON, (UPI) -- The Food and Drug Administrationon Friday approved a new breast cancer drug called Faslodex, whichrepresents a new class of drugs for treating the disease and mayoffer hope for women with advanced cancer which has failed torespond to other drugs.
Faslodex will give doctors a new way ofattacking advanced breast cancer, which is currently treated withtamoxifen and a class of drugs known as aromatase inhibitors,Kent Osborne, director of the breast center at Baylor collegeof medicine and Methodist hospital and principal investigatorin one of the trials of the drug, told United Press International.
"Faslodex is very effective in patientswith advanced breast cancer," Osborne added.
"I think it's actually going to bea big advance for patients," Dr. Kathy Miller, assistantprofessor of medicine at Indiana University, told United PressInternational. Miller is not associated with AstraZeneca, thedrug's manufacturer, and was not involved in the studies of Faslodex.
FDA approved the drug for treating postmenopausalwomen with advanced breast cancer that has spread from the breastto other areas of the body. Women receiving the drug also musthave failed to benefit from tamoxifen.
There is no cure for advanced breast cancerand women generally only survive for 2-3 years after developingthe condition, but it can be controlled. Faslodex adds anotherweapon to the arsenal of drugs that can be used to fight the cancer,although it will probably not improve length of survival, Millersaid.
Patients not responding well to aromataseinhibitors can be switched to Faslodex to see if they fare anybetter on that drug, or vice-versa, Miller said. Both Faslodexand aromatase inhibitors are about equally effective in treatingadvanced breast cancer, she said.
Even though the drug was approved for treatingpost-menopausal women, Miller said it probably will be used off-labelto treat premenopausal women with advanced breast cancer as well.
Faslodex works by binding to the body'sreceptors for the hormone estrogen and degrading those receptors.
This halts the cancer by preventing estrogenfrom reaching tumors. About 60 percent of breast cancer tumorsare classified as estrogen-sensitive, meaning estrogen will spurthem to grow.
Miller noted that tamoxifen also works bybinding estrogen receptors but does not degrade the receptors.Aromatase inhibitors fight cancer through a completely differentapproach by stopping the body's estrogen production.
Side effects associated with Faslodex, whichis given by injection once a month, are similar to other breastcancer drugs and include nausea, vomiting, headache and hot flashes.One advantage of Faslodex is that it does not increase the riskof developing uterine cancer or blood clots, as does tamoxifen,Mary Lynn Carver, spokeswoman for the manufacturer AstraZeneca,told UPI.
About 200,000 women are diagnosed with breastcancer each year in the United States. AstraZeneca expects thatmore than 40,000 women have advanced breast cancer and could benefitfrom Faslodex.
Doctors already can order the drug, andit should be available for widespread distribution by the endof May, Carver said.