"The controversial drug Avastin should be phased out as a treatment for metastatic breast cancer the Food and Drug Administration said Thursday citing recent studies that show its benefits may be outweighed by dangerous side effects. However patients currently taking Avastin as part of their chemotherapy regimen will not immediately be affected and doctors should use their medical judgment on whether to continue its use said Dr. Janet Woodcock of the FDAs Center for Drug Evaluation and Research. The announcement does not affect Avastins status as an approved therapy for lung cancer kidney cancer colorectal cancer and brain cancer. Reflecting splits in the medical community the European Medicines Agency said Thursday that Avastin would remain an approved therapy for breast cancer in European Union countries although only in one particular combination with the drug paclitaxel. Avastin first approved as a cancer treatment in  helps by inhibiting a tumors blood supply. In  the FDA granted Avastin whats known as accelerated approval of its use as a therapy for metastatic breast cancer  cancer that has spread from one part of the body to another. The move was based on data in one preliminary study known as E. At that time researchers reported that Avastin when used in combination with other drugs extended the time that patients went without their illness getting worse a measure known as progressionfree survival or PFS. Along with the initial approval the FDA required Genentech Avastins maker to complete larger studies. The results of those studies were a bitter pill for patients thriving on Avastin and researchers excited by the promise of the early data. The E study found that for women taking Avastin plus paclitaxel the cancer stopped spreading for an average of fiveandahalf months more compared to those just taking standard chemotherapy. In the subsequent three larger studies the benefit was much smaller ranging from just  days to about two months.  None of the studies including the E study showed that patients getting Avastin lived longer than patients on standard chemotherapies. We now have four studies that show no survival benefit Woodcock said.  Along with those disappointing findings serious side effects became apparent in patients taking Avastin including high blood pressure internal bleeding perforated internal organs heart failure and heart attacks and in some cases even swelling of the brain. Based on the new data an FDA advisory panel voted  to reverse the accelerated approval in July. Thursdays announcement is only a first step in removing the FDAs approval for this drug in treating breast cancer patients. As part of the complex process Genentech has a right to appeal and company spokeswoman Charlotte Arnold said it would request a hearing to press its case. Physicians who favor Avastins use say the FDA is being overly cautious and that the drug can be used safely if patients are closely monitored. This is a very sad and confusing day for our patients said Dr. Joseph Sparano of MontefioreEinstein Center for Cancer Care in New York. Survival was consistently better at one year in all of the studies indicating that this is a safe and effective option. What makes this even more frustrating is that the drug will still be available to prescribe but will only be an option for those who can afford it rather than those who really need it. Avastins cost which can run to several thousand dollars a month has sometimes been used as an example by critics of the health care system who fear that costcutting may win out over patient care. After the advisory committees decision in July Sen. David Vitter RLouisiana wrote a letter to the FDA complaining that the FDA advisory committees concerns appear to have been based on costeffectiveness and adding that a reversal on accelerated approval would amount to costrationing. The FDA says it does not consider cost when evaluating the safety or effectiveness of a drug. Dr. Len Lichtenfeld deputy chief medical officer of the American Cancer Society said its clear that some women with metastatic breast cancer have benefited from Avastin but others not only have not benefited theyve been harmed. What we clearly need is a way for doctors to more accurately predict which women will have a better chance of benefitting from this important targeted therapy he said in a statement on the American Cancer Society website. Thursday Woodcock held out the possibility that Avastin might eventually prove helpful in a targeted group of patients. We certainly hope that additional data could be generated to see if there is a subset of tumors that would respond more than others she said. The FDA stands ready to work with Genentech on future studies. Such research is already underway Arnold said but its too early to discuss the findings. This is something Genentech is very committed to. Our scientists are dedicated to learning more about who might derive a greater benefit from Avastin she explained."